ibuprofen

Generic: ibuprofen

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION 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 400 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-201
Product ID 72789-201_34180aa0-9db5-4fc8-e063-6394a90ab864
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078329
Listing Expiration 2026-12-31
Marketing Start 2020-08-21

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 72789201
Hyphenated Format 72789-201

Supplemental Identifiers

RxCUI
197805
UPC
0372789201207
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 ANDA078329 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-201-06)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-201-20)
  • 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-201-40)
source: ndc

Packages (3)

72789-201-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-201-06) 72789-201-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-201-20) 72789-201-40 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-201-40)

Ingredients (1)

ibuprofen (400 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": "34180aa0-9db5-4fc8-e063-6394a90ab864", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0372789201207"], "unii": ["WK2XYI10QM"], "rxcui": ["197805"], "spl_set_id": ["42b92fd7-468c-4fb8-9ff0-31296735df4c"], "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": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-201-06)", "package_ndc": "72789-201-06", "marketing_start_date": "20211215"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-201-20)", "package_ndc": "72789-201-20", "marketing_start_date": "20210824"}, {"sample": false, "description": "40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-201-40)", "package_ndc": "72789-201-40", "marketing_start_date": "20230315"}], "brand_name": "Ibuprofen", "product_id": "72789-201_34180aa0-9db5-4fc8-e063-6394a90ab864", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "72789-201", "generic_name": "Ibuprofen", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "400 mg/1"}], "application_number": "ANDA078329", "marketing_category": "ANDA", "marketing_start_date": "20200821", "listing_expiration_date": "20261231"}