ibuprofen

Generic: ibuprofen

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

Drug Facts

Product Profile

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

ibuprofen 400 mg/1

Manufacturer
EXELAN PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 76282-712
Product ID 76282-712_bc309c22-f359-42b1-86db-3970a5d53bc4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091625
Listing Expiration 2026-12-31
Marketing Start 2022-03-10

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 76282712
Hyphenated Format 76282-712

Supplemental Identifiers

RxCUI
197805 197806 197807
UPC
0376282714554 0376282712109 0376282714905 0376282713502 0376282714103 0376282714301 0376282713106 0376282713557 0376282714509 0376282712550 0376282712505
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 ANDA091625 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76282-712-10)
  • 100 BLISTER PACK in 1 CARTON (76282-712-46) / 10 TABLET, FILM COATED in 1 BLISTER PACK (76282-712-45)
  • 500 TABLET, FILM COATED in 1 BOTTLE (76282-712-50)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (76282-712-55)
source: ndc

Packages (4)

76282-712-10 100 TABLET, FILM COATED in 1 BOTTLE (76282-712-10) 76282-712-46 100 BLISTER PACK in 1 CARTON (76282-712-46) / 10 TABLET, FILM COATED in 1 BLISTER PACK (76282-712-45) 76282-712-50 500 TABLET, FILM COATED in 1 BOTTLE (76282-712-50) 76282-712-55 1000 TABLET, FILM COATED in 1 BOTTLE (76282-712-55)

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": "bc309c22-f359-42b1-86db-3970a5d53bc4", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0376282714554", "0376282712109", "0376282714905", "0376282713502", "0376282714103", "0376282714301", "0376282713106", "0376282713557", "0376282714509", "0376282712550", "0376282712505"], "unii": ["WK2XYI10QM"], "rxcui": ["197805", "197806", "197807"], "spl_set_id": ["362f934a-4382-43bc-bedd-65081286f1c9"], "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": ["EXELAN PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76282-712-10)", "package_ndc": "76282-712-10", "marketing_start_date": "20220310"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (76282-712-46)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (76282-712-45)", "package_ndc": "76282-712-46", "marketing_start_date": "20220310"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (76282-712-50)", "package_ndc": "76282-712-50", "marketing_start_date": "20220310"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (76282-712-55)", "package_ndc": "76282-712-55", "marketing_start_date": "20220310"}], "brand_name": "Ibuprofen", "product_id": "76282-712_bc309c22-f359-42b1-86db-3970a5d53bc4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76282-712", "generic_name": "Ibuprofen", "labeler_name": "EXELAN PHARMACEUTICALS, 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": "20220310", "listing_expiration_date": "20261231"}