ibuprofen

Generic: ibuprofen

Labeler: l.n.k. international, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler l.n.k. international, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
L.N.K. International, Inc.

Identifiers & Regulatory

Product NDC 50844-352
Product ID 50844-352_60c87666-dbaf-4d99-9985-b9a662198528
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075139
Listing Expiration 2027-12-31
Marketing Start 1999-03-01

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 50844352
Hyphenated Format 50844-352

Supplemental Identifiers

RxCUI
310965
UPC
0050844352162
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 ANDA075139 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (50844-352-02) / 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (50844-352-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (50844-352-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-352-16)
source: ndc

Packages (4)

50844-352-02 1 BOTTLE, PLASTIC in 1 CARTON (50844-352-02) / 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50844-352-12 1 BOTTLE, PLASTIC in 1 CARTON (50844-352-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50844-352-15 1 BOTTLE, PLASTIC in 1 CARTON (50844-352-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50844-352-16 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-352-16)

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": "60c87666-dbaf-4d99-9985-b9a662198528", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0050844352162"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["8ebe3e16-b7ae-d333-6671-5bc935e25900"], "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": ["L.N.K. International, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50844-352-02)  / 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50844-352-02", "marketing_start_date": "19990301"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50844-352-12)  / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50844-352-12", "marketing_start_date": "19990301"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50844-352-15)  / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50844-352-15", "marketing_start_date": "19990301"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-352-16)", "package_ndc": "50844-352-16", "marketing_start_date": "19990301"}], "brand_name": "Ibuprofen", "product_id": "50844-352_60c87666-dbaf-4d99-9985-b9a662198528", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50844-352", "generic_name": "ibuprofen", "labeler_name": "L.N.K. International, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA075139", "marketing_category": "ANDA", "marketing_start_date": "19990301", "listing_expiration_date": "20271231"}