acetaminophen and ibuprofen back pain

Generic: acetaminophen and ibuprofen

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen and ibuprofen back pain
Generic Name acetaminophen and ibuprofen
Labeler aurohealth llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 250 mg/1, ibuprofen 125 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-895
Product ID 58602-895_62d7ce90-63a4-4383-87c9-3a458eac29bf
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA218359
Listing Expiration 2026-12-31
Marketing Start 2024-03-26

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602895
Hyphenated Format 58602-895

Supplemental Identifiers

RxCUI
2387532
UNII
362O9ITL9D WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name acetaminophen and ibuprofen back pain (source: ndc)
Generic Name acetaminophen and ibuprofen (source: ndc)
Application Number ANDA218359 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE in 1 CARTON (58602-895-03) / 10 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-895-07) / 24 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-895-11) / 36 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-895-14) / 50 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-895-21) / 100 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-895-29) / 150 TABLET, FILM COATED in 1 BOTTLE
  • 225 TABLET, FILM COATED in 1 BOTTLE (58602-895-35)
  • 500 TABLET, FILM COATED in 1 BOTTLE (58602-895-40)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (58602-895-41)
  • 400 TABLET, FILM COATED in 1 BOTTLE (58602-895-44)
  • 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-46) / 18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-49) / 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 216 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-51)
  • 1 BLISTER PACK in 1 CARTON (58602-895-61) / 2 TABLET, FILM COATED in 1 BLISTER PACK
  • 216 TABLET, FILM COATED in 1 BOTTLE (58602-895-62)
  • 1 BOTTLE in 1 CARTON (58602-895-65) / 72 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-895-73) / 20 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-78) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-79)
  • 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-80) / 72 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE in 1 CARTON (58602-895-82) / 18 TABLET, FILM COATED in 1 BOTTLE
  • 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-84)
  • 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-85) / 36 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 750 TABLET, FILM COATED in 1 BOTTLE (58602-895-88)
  • 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-94) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 750 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-95)
  • 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-96) / 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-99)
source: ndc

Packages (29)

58602-895-01 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 58602-895-03 1 BOTTLE in 1 CARTON (58602-895-03) / 10 TABLET, FILM COATED in 1 BOTTLE 58602-895-07 1 BOTTLE in 1 CARTON (58602-895-07) / 24 TABLET, FILM COATED in 1 BOTTLE 58602-895-11 1 BOTTLE in 1 CARTON (58602-895-11) / 36 TABLET, FILM COATED in 1 BOTTLE 58602-895-14 1 BOTTLE in 1 CARTON (58602-895-14) / 50 TABLET, FILM COATED in 1 BOTTLE 58602-895-21 1 BOTTLE in 1 CARTON (58602-895-21) / 100 TABLET, FILM COATED in 1 BOTTLE 58602-895-29 1 BOTTLE in 1 CARTON (58602-895-29) / 150 TABLET, FILM COATED in 1 BOTTLE 58602-895-35 225 TABLET, FILM COATED in 1 BOTTLE (58602-895-35) 58602-895-40 500 TABLET, FILM COATED in 1 BOTTLE (58602-895-40) 58602-895-41 1000 TABLET, FILM COATED in 1 BOTTLE (58602-895-41) 58602-895-44 400 TABLET, FILM COATED in 1 BOTTLE (58602-895-44) 58602-895-46 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-46) / 18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 58602-895-49 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-49) / 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 58602-895-51 216 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-51) 58602-895-61 1 BLISTER PACK in 1 CARTON (58602-895-61) / 2 TABLET, FILM COATED in 1 BLISTER PACK 58602-895-62 216 TABLET, FILM COATED in 1 BOTTLE (58602-895-62) 58602-895-65 1 BOTTLE in 1 CARTON (58602-895-65) / 72 TABLET, FILM COATED in 1 BOTTLE 58602-895-73 1 BOTTLE in 1 CARTON (58602-895-73) / 20 TABLET, FILM COATED in 1 BOTTLE 58602-895-78 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-78) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 58602-895-79 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-79) 58602-895-80 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-80) / 72 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 58602-895-82 1 BOTTLE in 1 CARTON (58602-895-82) / 18 TABLET, FILM COATED in 1 BOTTLE 58602-895-84 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-84) 58602-895-85 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-85) / 36 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 58602-895-88 750 TABLET, FILM COATED in 1 BOTTLE (58602-895-88) 58602-895-94 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-94) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 58602-895-95 750 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-95) 58602-895-96 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-96) / 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 58602-895-99 400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-99)

Ingredients (2)

acetaminophen (250 mg/1) ibuprofen (125 mg/1)

Linked Drug Pages (1)

Acetaminophen and Ibuprofen Back Pain ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "62d7ce90-63a4-4383-87c9-3a458eac29bf", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["62d7ce90-63a4-4383-87c9-3a458eac29bf"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58602-895-01)  / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "58602-895-01", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-895-03)  / 10 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-895-03", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-895-07)  / 24 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-895-07", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-895-11)  / 36 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-895-11", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-895-14)  / 50 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-895-14", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-895-21)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-895-21", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-895-29)  / 150 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-895-29", "marketing_start_date": "20240326"}, {"sample": false, "description": "225 TABLET, FILM COATED in 1 BOTTLE (58602-895-35)", "package_ndc": "58602-895-35", "marketing_start_date": "20240326"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (58602-895-40)", "package_ndc": "58602-895-40", "marketing_start_date": "20240326"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (58602-895-41)", "package_ndc": "58602-895-41", "marketing_start_date": "20240326"}, {"sample": false, "description": "400 TABLET, FILM COATED in 1 BOTTLE (58602-895-44)", "package_ndc": "58602-895-44", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58602-895-46)  / 18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "58602-895-46", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58602-895-49)  / 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "58602-895-49", "marketing_start_date": "20240326"}, {"sample": false, "description": "216 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-51)", "package_ndc": "58602-895-51", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-895-61)  / 2 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "58602-895-61", "marketing_start_date": "20240326"}, {"sample": false, "description": "216 TABLET, FILM COATED in 1 BOTTLE (58602-895-62)", "package_ndc": "58602-895-62", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-895-65)  / 72 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-895-65", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-895-73)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-895-73", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58602-895-78)  / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "58602-895-78", "marketing_start_date": "20240326"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-79)", "package_ndc": "58602-895-79", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58602-895-80)  / 72 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "58602-895-80", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-895-82)  / 18 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-895-82", "marketing_start_date": "20240326"}, {"sample": false, "description": "225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-84)", "package_ndc": "58602-895-84", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58602-895-85)  / 36 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "58602-895-85", "marketing_start_date": "20240326"}, {"sample": false, "description": "750 TABLET, FILM COATED in 1 BOTTLE (58602-895-88)", "package_ndc": "58602-895-88", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58602-895-94)  / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "58602-895-94", "marketing_start_date": "20240326"}, {"sample": false, "description": "750 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-95)", "package_ndc": "58602-895-95", "marketing_start_date": "20240326"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58602-895-96)  / 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "58602-895-96", "marketing_start_date": "20240326"}, {"sample": false, "description": "400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-99)", "package_ndc": "58602-895-99", "marketing_start_date": "20240326"}], "brand_name": "Acetaminophen and Ibuprofen Back Pain", "product_id": "58602-895_62d7ce90-63a4-4383-87c9-3a458eac29bf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "58602-895", "generic_name": "Acetaminophen and Ibuprofen", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen and Ibuprofen Back Pain", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "IBUPROFEN", "strength": "125 mg/1"}], "application_number": "ANDA218359", "marketing_category": "ANDA", "marketing_start_date": "20240326", "listing_expiration_date": "20261231"}