ibuprofen

Generic: ibuprofen

Labeler: pld acquisitions llc dba avma pharma solutions
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler pld acquisitions llc dba avma pharma solutions
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
PLD Acquisitions LLC DBA Avma Pharma Solutions

Identifiers & Regulatory

Product NDC 63548-0234
Product ID 63548-0234_616902bc-ffd6-41d3-ae4d-6e30519147c0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076460
Listing Expiration 2026-12-31
Marketing Start 2013-08-01

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 635480234
Hyphenated Format 63548-0234

Supplemental Identifiers

RxCUI
310965
UPC
0359726234016 0359726234009 0359726234108
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 ANDA076460 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 10 TABLET, COATED in 1 VIAL (63548-0234-1)
  • 1 BOTTLE in 1 BOX (63548-0234-2) / 100 TABLET, COATED in 1 BOTTLE
  • 1000 TABLET, COATED in 1 BOTTLE (63548-0234-3)
source: ndc

Packages (3)

63548-0234-1 10 TABLET, COATED in 1 VIAL (63548-0234-1) 63548-0234-2 1 BOTTLE in 1 BOX (63548-0234-2) / 100 TABLET, COATED in 1 BOTTLE 63548-0234-3 1000 TABLET, COATED in 1 BOTTLE (63548-0234-3)

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": "616902bc-ffd6-41d3-ae4d-6e30519147c0", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0359726234016", "0359726234009", "0359726234108"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["1662a495-4f6a-4515-a405-557681e1a496"], "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": ["PLD Acquisitions LLC DBA Avma Pharma Solutions"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, COATED in 1 VIAL (63548-0234-1)", "package_ndc": "63548-0234-1", "marketing_start_date": "20130801"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (63548-0234-2)  / 100 TABLET, COATED in 1 BOTTLE", "package_ndc": "63548-0234-2", "marketing_start_date": "20130801"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (63548-0234-3)", "package_ndc": "63548-0234-3", "marketing_start_date": "20130801"}], "brand_name": "Ibuprofen", "product_id": "63548-0234_616902bc-ffd6-41d3-ae4d-6e30519147c0", "dosage_form": "TABLET, COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "63548-0234", "generic_name": "Ibuprofen", "labeler_name": "PLD Acquisitions LLC DBA Avma Pharma Solutions", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA076460", "marketing_category": "ANDA", "marketing_start_date": "20130801", "listing_expiration_date": "20261231"}