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 43063-872
Product ID 43063-872_303d4f9d-cb3f-1bfa-e063-6294a90a16aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090796
Listing Expiration 2026-12-31
Marketing Start 2015-12-30

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 43063872
Hyphenated Format 43063-872

Supplemental Identifiers

RxCUI
197805
UPC
0343063872307
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 ANDA090796 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-06)
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-10)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-30)
  • 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-40)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-82)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-90)
source: ndc

Packages (7)

43063-872-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-06) 43063-872-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-10) 43063-872-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-20) 43063-872-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-30) 43063-872-40 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-40) 43063-872-82 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-82) 43063-872-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-90)

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": "303d4f9d-cb3f-1bfa-e063-6294a90a16aa", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0343063872307"], "unii": ["WK2XYI10QM"], "rxcui": ["197805"], "spl_set_id": ["ce5b0429-bbe1-47a4-af5e-0159d3cfd2c3"], "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 (43063-872-06)", "package_ndc": "43063-872-06", "marketing_start_date": "20190125"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-10)", "package_ndc": "43063-872-10", "marketing_start_date": "20190429"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-20)", "package_ndc": "43063-872-20", "marketing_start_date": "20180807"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-30)", "package_ndc": "43063-872-30", "marketing_start_date": "20180807"}, {"sample": false, "description": "40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-40)", "package_ndc": "43063-872-40", "marketing_start_date": "20180807"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-82)", "package_ndc": "43063-872-82", "marketing_start_date": "20190302"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-90)", "package_ndc": "43063-872-90", "marketing_start_date": "20190426"}], "brand_name": "Ibuprofen", "product_id": "43063-872_303d4f9d-cb3f-1bfa-e063-6294a90a16aa", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "43063-872", "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": "ANDA090796", "marketing_category": "ANDA", "marketing_start_date": "20151230", "listing_expiration_date": "20261231"}