ibuprofen

Generic: ibuprofen

Labeler: sam's west inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler sam's west inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Sam's West Inc

Identifiers & Regulatory

Product NDC 68196-291
Product ID 68196-291_f8cdb164-4649-4f7b-bbed-31675c05b9f0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075010
Listing Expiration 2026-12-31
Marketing Start 1988-05-24

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 68196291
Hyphenated Format 68196-291

Supplemental Identifiers

RxCUI
310965
UPC
0193968328122
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
  • 600 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68196-291-78)
source: ndc

Packages (1)

68196-291-78 600 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68196-291-78)

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": "f8cdb164-4649-4f7b-bbed-31675c05b9f0", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0193968328122"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["6293a134-860d-4d12-9e4b-28490f824108"], "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": ["Sam's West Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "600 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68196-291-78)", "package_ndc": "68196-291-78", "marketing_start_date": "19880524"}], "brand_name": "Ibuprofen", "product_id": "68196-291_f8cdb164-4649-4f7b-bbed-31675c05b9f0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68196-291", "generic_name": "Ibuprofen", "labeler_name": "Sam's West Inc", "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": "19880524", "listing_expiration_date": "20261231"}