ibuprofen

Generic: ibuprofen

Labeler: dolgencorp, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler dolgencorp, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
DOLGENCORP, LLC

Identifiers & Regulatory

Product NDC 55910-791
Product ID 55910-791_ab690460-e705-4a04-a047-acaf76aa9aca
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075010
Listing Expiration 2027-12-31
Marketing Start 2023-05-12

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 55910791
Hyphenated Format 55910-791

Supplemental Identifiers

RxCUI
310965
UPC
0350844991966
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
  • 1 BOTTLE, PLASTIC in 1 CARTON (55910-791-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 2 BOTTLE, PLASTIC in 1 CARTON (55910-791-96) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

55910-791-08 1 BOTTLE, PLASTIC in 1 CARTON (55910-791-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 55910-791-96 2 BOTTLE, PLASTIC in 1 CARTON (55910-791-96) / 100 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": "ab690460-e705-4a04-a047-acaf76aa9aca", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0350844991966"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["37ccb303-c70e-48b3-a8a3-2b0097cf8f88"], "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": ["DOLGENCORP, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (55910-791-08)  / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "55910-791-08", "marketing_start_date": "20230512"}, {"sample": false, "description": "2 BOTTLE, PLASTIC in 1 CARTON (55910-791-96)  / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "55910-791-96", "marketing_start_date": "20230512"}], "brand_name": "Ibuprofen", "product_id": "55910-791_ab690460-e705-4a04-a047-acaf76aa9aca", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "55910-791", "generic_name": "Ibuprofen", "labeler_name": "DOLGENCORP, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA075010", "marketing_category": "ANDA", "marketing_start_date": "20230512", "listing_expiration_date": "20271231"}