ibuprofen

Generic: ibuprofen

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

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler aurohealth llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-843
Product ID 58602-843_4a614548-3e17-4ead-97d2-634996a5b490
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207753
Listing Expiration 2026-12-31
Marketing Start 2020-07-15

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 58602843
Hyphenated Format 58602-843

Supplemental Identifiers

RxCUI
310964
UNII
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 ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA207753 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58602-843-12) / 40 CAPSULE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-843-18) / 80 CAPSULE in 1 BOTTLE
  • 160 CAPSULE in 1 BOTTLE (58602-843-30)
  • 180 CAPSULE in 1 BOTTLE (58602-843-32)
  • 200 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-34)
  • 300 CAPSULE in 1 BOTTLE (58602-843-38)
  • 1 BOTTLE, PLASTIC in 1 CARTON (58602-843-70) / 40 CAPSULE in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (58602-843-72) / 80 CAPSULE in 1 BOTTLE, PLASTIC
  • 1 BOTTLE in 1 CARTON (58602-843-73) / 20 CAPSULE in 1 BOTTLE
  • 160 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-74)
  • 300 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-75)
  • 2 BOTTLE in 1 CARTON (58602-843-79) / 180 CAPSULE in 1 BOTTLE
  • 180 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-92)
source: ndc

Packages (13)

58602-843-12 1 BOTTLE in 1 CARTON (58602-843-12) / 40 CAPSULE in 1 BOTTLE 58602-843-18 1 BOTTLE in 1 CARTON (58602-843-18) / 80 CAPSULE in 1 BOTTLE 58602-843-30 160 CAPSULE in 1 BOTTLE (58602-843-30) 58602-843-32 180 CAPSULE in 1 BOTTLE (58602-843-32) 58602-843-34 200 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-34) 58602-843-38 300 CAPSULE in 1 BOTTLE (58602-843-38) 58602-843-70 1 BOTTLE, PLASTIC in 1 CARTON (58602-843-70) / 40 CAPSULE in 1 BOTTLE, PLASTIC 58602-843-72 1 BOTTLE, PLASTIC in 1 CARTON (58602-843-72) / 80 CAPSULE in 1 BOTTLE, PLASTIC 58602-843-73 1 BOTTLE in 1 CARTON (58602-843-73) / 20 CAPSULE in 1 BOTTLE 58602-843-74 160 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-74) 58602-843-75 300 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-75) 58602-843-79 2 BOTTLE in 1 CARTON (58602-843-79) / 180 CAPSULE in 1 BOTTLE 58602-843-92 180 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-92)

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a614548-3e17-4ead-97d2-634996a5b490", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310964"], "spl_set_id": ["7779c369-50bf-4cde-9015-ff3fb35e128e"], "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 in 1 CARTON (58602-843-12)  / 40 CAPSULE in 1 BOTTLE", "package_ndc": "58602-843-12", "marketing_start_date": "20200715"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-843-18)  / 80 CAPSULE in 1 BOTTLE", "package_ndc": "58602-843-18", "marketing_start_date": "20200715"}, {"sample": false, "description": "160 CAPSULE in 1 BOTTLE (58602-843-30)", "package_ndc": "58602-843-30", "marketing_start_date": "20200715"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE (58602-843-32)", "package_ndc": "58602-843-32", "marketing_start_date": "20200715"}, {"sample": false, "description": "200 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-34)", "package_ndc": "58602-843-34", "marketing_start_date": "20200827"}, {"sample": false, "description": "300 CAPSULE in 1 BOTTLE (58602-843-38)", "package_ndc": "58602-843-38", "marketing_start_date": "20200715"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58602-843-70)  / 40 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "58602-843-70", "marketing_start_date": "20200827"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58602-843-72)  / 80 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "58602-843-72", "marketing_start_date": "20200827"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-843-73)  / 20 CAPSULE in 1 BOTTLE", "package_ndc": "58602-843-73", "marketing_start_date": "20200715"}, {"sample": false, "description": "160 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-74)", "package_ndc": "58602-843-74", "marketing_start_date": "20200827"}, {"sample": false, "description": "300 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-75)", "package_ndc": "58602-843-75", "marketing_start_date": "20200827"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (58602-843-79)  / 180 CAPSULE in 1 BOTTLE", "package_ndc": "58602-843-79", "marketing_start_date": "20200715"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-92)", "package_ndc": "58602-843-92", "marketing_start_date": "20200827"}], "brand_name": "Ibuprofen", "product_id": "58602-843_4a614548-3e17-4ead-97d2-634996a5b490", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "58602-843", "generic_name": "Ibuprofen", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA207753", "marketing_category": "ANDA", "marketing_start_date": "20200715", "listing_expiration_date": "20261231"}