ibuprofen

Generic: ibuprofen

Labeler: chain drug consortium
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler chain drug consortium
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Chain Drug Consortium

Identifiers & Regulatory

Product NDC 68016-634
Product ID 68016-634_4ce3d600-a2ba-4e98-b513-e6e5884ae9a2
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075010
Marketing Start 1988-05-24
Marketing End 2027-02-28

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 68016634
Hyphenated Format 68016-634

Supplemental Identifiers

RxCUI
310965
UPC
0840986031571
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 ANDA075010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-00)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-05)
  • 1 BOTTLE, PLASTIC in 1 CARTON (68016-634-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (68016-634-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-25)
  • 1 BOTTLE, PLASTIC in 1 CARTON (68016-634-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (6)

68016-634-00 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-00) 68016-634-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-05) 68016-634-10 1 BOTTLE, PLASTIC in 1 CARTON (68016-634-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 68016-634-24 1 BOTTLE, PLASTIC in 1 CARTON (68016-634-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 68016-634-25 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-25) 68016-634-50 1 BOTTLE, PLASTIC in 1 CARTON (68016-634-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

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": "4ce3d600-a2ba-4e98-b513-e6e5884ae9a2", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0840986031571"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["6c593a9c-680e-4645-8e8f-d8d044c92ca1"], "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": ["Chain Drug Consortium"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-00)", "package_ndc": "68016-634-00", "marketing_end_date": "20270228", "marketing_start_date": "19880524"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-05)", "package_ndc": "68016-634-05", "marketing_end_date": "20270228", "marketing_start_date": "19880524"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (68016-634-10)  / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "68016-634-10", "marketing_end_date": "20270228", "marketing_start_date": "19880524"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (68016-634-24)  / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "68016-634-24", "marketing_end_date": "20270228", "marketing_start_date": "19880524"}, {"sample": false, "description": "250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-25)", "package_ndc": "68016-634-25", "marketing_end_date": "20270228", "marketing_start_date": "19880524"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (68016-634-50)  / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "68016-634-50", "marketing_end_date": "20270228", "marketing_start_date": "19880524"}], "brand_name": "Ibuprofen", "product_id": "68016-634_4ce3d600-a2ba-4e98-b513-e6e5884ae9a2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68016-634", "generic_name": "Ibuprofen", "labeler_name": "Chain Drug Consortium", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA075010", "marketing_category": "ANDA", "marketing_end_date": "20270228", "marketing_start_date": "19880524"}