ibuprofen pain releiver/ fever reducer

Generic: ibuprofen

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

Drug Facts

Product Profile

Brand Name ibuprofen pain releiver/ fever reducer
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 53746-140
Product ID 53746-140_e2b9bf54-0449-4f9b-86e8-e3b292387dd5
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA071333
Listing Expiration 2026-12-31
Marketing Start 2009-12-16

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 53746140
Hyphenated Format 53746-140

Supplemental Identifiers

RxCUI
310965
UPC
0353746144249
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 pain releiver/ fever reducer (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA071333 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53746-140-01)
  • 1000 TABLET in 1 BOTTLE (53746-140-10)
  • 24 TABLET in 1 BOTTLE (53746-140-24)
source: ndc

Packages (3)

53746-140-01 100 TABLET in 1 BOTTLE (53746-140-01) 53746-140-10 1000 TABLET in 1 BOTTLE (53746-140-10) 53746-140-24 24 TABLET in 1 BOTTLE (53746-140-24)

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

Ibuprofen Pain Releiver/ Fever Reducer ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e2b9bf54-0449-4f9b-86e8-e3b292387dd5", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0353746144249"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["ee241be0-35f8-4789-a71f-98de31d6a590"], "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": "100 TABLET in 1 BOTTLE (53746-140-01)", "package_ndc": "53746-140-01", "marketing_start_date": "20091216"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (53746-140-10)", "package_ndc": "53746-140-10", "marketing_start_date": "20091216"}, {"sample": false, "description": "24 TABLET in 1 BOTTLE (53746-140-24)", "package_ndc": "53746-140-24", "marketing_start_date": "20091216"}], "brand_name": "Ibuprofen Pain Releiver/ Fever Reducer", "product_id": "53746-140_e2b9bf54-0449-4f9b-86e8-e3b292387dd5", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53746-140", "generic_name": "Ibuprofen", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "brand_name_suffix": "Pain Releiver/ Fever Reducer", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA071333", "marketing_category": "ANDA", "marketing_start_date": "20091216", "listing_expiration_date": "20261231"}