ibuprofen

Generic: ibuprofen

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-191
Product ID 72789-191_460208a0-114d-960f-e063-6294a90a0981
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA072096
Listing Expiration 2026-12-31
Marketing Start 2018-09-20

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 72789191
Hyphenated Format 72789-191

Supplemental Identifiers

RxCUI
310965
UNII
WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

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 ANDA072096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-191-20)
  • 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-191-21)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-191-30)
source: ndc

Packages (3)

72789-191-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-191-20) 72789-191-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-191-21) 72789-191-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-191-30)

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": "460208a0-114d-960f-e063-6294a90a0981", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["96bff700-bca3-4b94-b8a2-379102721db8"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-191-20)", "package_ndc": "72789-191-20", "marketing_start_date": "20230509"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-191-21)", "package_ndc": "72789-191-21", "marketing_start_date": "20251215"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-191-30)", "package_ndc": "72789-191-30", "marketing_start_date": "20210601"}], "brand_name": "ibuprofen", "product_id": "72789-191_460208a0-114d-960f-e063-6294a90a0981", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "72789-191", "generic_name": "Ibuprofen", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA072096", "marketing_category": "ANDA", "marketing_start_date": "20180920", "listing_expiration_date": "20261231"}