acetaminophen, ibuprofen

Generic: acetaminophen, ibuprofen

Labeler: glenmark therapeutics inc., usa
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen, ibuprofen
Generic Name acetaminophen, ibuprofen
Labeler glenmark therapeutics inc., usa
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 250 mg/1, ibuprofen 125 mg/1

Manufacturer
GLENMARK THERAPEUTICS INC., USA

Identifiers & Regulatory

Product NDC 72657-157
Product ID 72657-157_b3d8d869-735e-4720-8b2b-a3eacc92041f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA218311
Listing Expiration 2027-12-31
Marketing Start 2024-05-07

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 72657157
Hyphenated Format 72657-157

Supplemental Identifiers

RxCUI
2387532
UPC
0372657157742
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, ibuprofen (source: ndc)
Generic Name acetaminophen, ibuprofen (source: ndc)
Application Number ANDA218311 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (72657-157-05) / 500 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-157-18) / 18 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-157-20) / 250 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-157-36) / 36 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-157-72) / 72 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-157-74) / 144 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-157-76) / 216 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (7)

72657-157-05 1 BOTTLE in 1 CARTON (72657-157-05) / 500 TABLET, FILM COATED in 1 BOTTLE 72657-157-18 1 BOTTLE in 1 CARTON (72657-157-18) / 18 TABLET, FILM COATED in 1 BOTTLE 72657-157-20 1 BOTTLE in 1 CARTON (72657-157-20) / 250 TABLET, FILM COATED in 1 BOTTLE 72657-157-36 1 BOTTLE in 1 CARTON (72657-157-36) / 36 TABLET, FILM COATED in 1 BOTTLE 72657-157-72 1 BOTTLE in 1 CARTON (72657-157-72) / 72 TABLET, FILM COATED in 1 BOTTLE 72657-157-74 1 BOTTLE in 1 CARTON (72657-157-74) / 144 TABLET, FILM COATED in 1 BOTTLE 72657-157-76 1 BOTTLE in 1 CARTON (72657-157-76) / 216 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

Acetaminophen, Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b3d8d869-735e-4720-8b2b-a3eacc92041f", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0372657157742"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["57a8dc2b-a3bc-49fa-b605-2330155bdbff"], "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": ["GLENMARK THERAPEUTICS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-157-05)  / 500 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "72657-157-05", "marketing_start_date": "20240507"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-157-18)  / 18 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "72657-157-18", "marketing_start_date": "20240507"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-157-20)  / 250 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "72657-157-20", "marketing_start_date": "20240507"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-157-36)  / 36 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "72657-157-36", "marketing_start_date": "20240507"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-157-72)  / 72 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "72657-157-72", "marketing_start_date": "20240507"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-157-74)  / 144 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "72657-157-74", "marketing_start_date": "20240507"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-157-76)  / 216 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "72657-157-76", "marketing_start_date": "20240507"}], "brand_name": "Acetaminophen, Ibuprofen", "product_id": "72657-157_b3d8d869-735e-4720-8b2b-a3eacc92041f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "72657-157", "generic_name": "Acetaminophen, Ibuprofen", "labeler_name": "GLENMARK THERAPEUTICS INC., USA", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen, Ibuprofen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "IBUPROFEN", "strength": "125 mg/1"}], "application_number": "ANDA218311", "marketing_category": "ANDA", "marketing_start_date": "20240507", "listing_expiration_date": "20271231"}