ibuprofen

Generic: ibuprofen

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-462
Product ID 53746-462_0a178197-17b9-4e74-a85b-abd0ba469966
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079233
Listing Expiration 2026-12-31
Marketing Start 2013-04-30

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 53746462
Hyphenated Format 53746-462

Supplemental Identifiers

RxCUI
310965
UPC
0353746462022 0353746458025 0353746460028
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 ANDA079233 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 250 TABLET in 1 BOTTLE (53746-462-02)
  • 1000 TABLET in 1 BOTTLE (53746-462-10)
source: ndc

Packages (2)

53746-462-02 250 TABLET in 1 BOTTLE (53746-462-02) 53746-462-10 1000 TABLET in 1 BOTTLE (53746-462-10)

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": "0a178197-17b9-4e74-a85b-abd0ba469966", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0353746462022", "0353746458025", "0353746460028"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["59f14d2b-f48a-4c25-bea3-3dc9100898b2"], "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": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "250 TABLET in 1 BOTTLE (53746-462-02)", "package_ndc": "53746-462-02", "marketing_start_date": "20130430"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (53746-462-10)", "package_ndc": "53746-462-10", "marketing_start_date": "20130430"}], "brand_name": "Ibuprofen", "product_id": "53746-462_0a178197-17b9-4e74-a85b-abd0ba469966", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53746-462", "generic_name": "Ibuprofen", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA079233", "marketing_category": "ANDA", "marketing_start_date": "20130430", "listing_expiration_date": "20261231"}