ibuprofen

Generic: ibuprofen

Labeler: pharmpak, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler pharmpak, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 400 mg/1

Manufacturer
PharmPak, Inc.

Identifiers & Regulatory

Product NDC 54348-835
Product ID 54348-835_eaa5cc60-19cc-a3f1-e053-2995a90a968f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091625
Listing Expiration 2026-12-31
Marketing Start 2019-07-11

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 54348835
Hyphenated Format 54348-835

Supplemental Identifiers

RxCUI
197805
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 ANDA091625 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (54348-835-00) / 1 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-835-08) / 8 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-835-10) / 10 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-835-12) / 12 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-835-20) / 20 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-835-30) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-835-60) / 60 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (7)

54348-835-00 1 BOTTLE in 1 BOX (54348-835-00) / 1 TABLET, FILM COATED in 1 BOTTLE 54348-835-08 1 BOTTLE in 1 BOX (54348-835-08) / 8 TABLET, FILM COATED in 1 BOTTLE 54348-835-10 1 BOTTLE in 1 BOX (54348-835-10) / 10 TABLET, FILM COATED in 1 BOTTLE 54348-835-12 1 BOTTLE in 1 BOX (54348-835-12) / 12 TABLET, FILM COATED in 1 BOTTLE 54348-835-20 1 BOTTLE in 1 BOX (54348-835-20) / 20 TABLET, FILM COATED in 1 BOTTLE 54348-835-30 1 BOTTLE in 1 BOX (54348-835-30) / 30 TABLET, FILM COATED in 1 BOTTLE 54348-835-60 1 BOTTLE in 1 BOX (54348-835-60) / 60 TABLET, FILM COATED in 1 BOTTLE

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": "eaa5cc60-19cc-a3f1-e053-2995a90a968f", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197805"], "spl_set_id": ["bb6d0547-c113-42f9-8bf2-c227a55ab758"], "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": ["PharmPak, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (54348-835-00)  / 1 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-835-00", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-835-08)  / 8 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-835-08", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-835-10)  / 10 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-835-10", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-835-12)  / 12 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-835-12", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-835-20)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-835-20", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-835-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-835-30", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-835-60)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-835-60", "marketing_start_date": "20190711"}], "brand_name": "Ibuprofen", "product_id": "54348-835_eaa5cc60-19cc-a3f1-e053-2995a90a968f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "54348-835", "generic_name": "IBUPROFEN", "labeler_name": "PharmPak, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "400 mg/1"}], "application_number": "ANDA091625", "marketing_category": "ANDA", "marketing_start_date": "20190711", "listing_expiration_date": "20261231"}