ibuprofen

Generic: ibuprofen

Labeler: demoulas super markets, inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler demoulas super markets, inc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Demoulas Super Markets, Inc

Identifiers & Regulatory

Product NDC 53942-112
Product ID 53942-112_3a0d9cac-feac-139d-e063-6294a90a30c8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA202312
Listing Expiration 2026-12-31
Marketing Start 2025-07-16

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 53942112
Hyphenated Format 53942-112

Supplemental Identifiers

RxCUI
310965
UPC
0049705745557
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 ANDA202312 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (53942-112-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

53942-112-03 1 BOTTLE, PLASTIC in 1 CARTON (53942-112-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC

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": "3a0d9cac-feac-139d-e063-6294a90a30c8", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0049705745557"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["39802e26-1028-d2fe-e063-6394a90a24c7"], "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": ["Demoulas Super Markets, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (53942-112-03)  / 100 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "53942-112-03", "marketing_start_date": "20250716"}], "brand_name": "Ibuprofen", "product_id": "53942-112_3a0d9cac-feac-139d-e063-6294a90a30c8", "dosage_form": "TABLET, COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53942-112", "generic_name": "Ibuprofen", "labeler_name": "Demoulas Super Markets, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA202312", "marketing_category": "ANDA", "marketing_start_date": "20250716", "listing_expiration_date": "20261231"}