acetaminophen and ibuprofen

Generic: acetaminophen and ibuprofen

Labeler: discount drug mart, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen and ibuprofen
Generic Name acetaminophen and ibuprofen
Labeler discount drug mart, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 250 mg/1, ibuprofen 125 mg/1

Manufacturer
DISCOUNT DRUG MART, INC.

Identifiers & Regulatory

Product NDC 53943-034
Product ID 53943-034_45c4564c-48b1-71b0-e063-6294a90a4180
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA216999
Listing Expiration 2026-12-31
Marketing Start 2023-09-08

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 53943034
Hyphenated Format 53943-034

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 (source: ndc)
Generic Name acetaminophen and ibuprofen (source: ndc)
Application Number ANDA216999 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 72 TABLET, FILM COATED in 1 CARTON (53943-034-76)
source: ndc

Packages (1)

53943-034-76 72 TABLET, FILM COATED in 1 CARTON (53943-034-76)

Ingredients (2)

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

Linked Drug Pages (1)

Acetaminophen and Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45c4564c-48b1-71b0-e063-6294a90a4180", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["f9dfeb0e-0d4d-7348-e053-6394a90a8aef"], "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": ["DISCOUNT DRUG MART, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "72 TABLET, FILM COATED in 1 CARTON (53943-034-76)", "package_ndc": "53943-034-76", "marketing_start_date": "20230908"}], "brand_name": "Acetaminophen and Ibuprofen", "product_id": "53943-034_45c4564c-48b1-71b0-e063-6294a90a4180", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53943-034", "generic_name": "Acetaminophen and Ibuprofen", "labeler_name": "DISCOUNT DRUG MART, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen and Ibuprofen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "IBUPROFEN", "strength": "125 mg/1"}], "application_number": "ANDA216999", "marketing_category": "ANDA", "marketing_start_date": "20230908", "listing_expiration_date": "20261231"}