ibuprofen

Generic: ibuprofen

Labeler: marc glassman, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler marc glassman, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
MARC GLASSMAN, INC.

Identifiers & Regulatory

Product NDC 68998-012
Product ID 68998-012_39f818d9-9278-c256-e063-6294a90a5e65
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA202312
Listing Expiration 2026-12-31
Marketing Start 2020-03-01

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 68998012
Hyphenated Format 68998-012

Supplemental Identifiers

RxCUI
310965
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 ANDA202312 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 PACKAGE in 1 CARTON (68998-012-03) / 100 TABLET, COATED in 1 PACKAGE
source: ndc

Packages (1)

68998-012-03 1 PACKAGE in 1 CARTON (68998-012-03) / 100 TABLET, COATED in 1 PACKAGE

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": "39f818d9-9278-c256-e063-6294a90a5e65", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["9714de6b-068b-d6b9-e053-2995a90a3b27"], "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": ["MARC GLASSMAN, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 PACKAGE in 1 CARTON (68998-012-03)  / 100 TABLET, COATED in 1 PACKAGE", "package_ndc": "68998-012-03", "marketing_start_date": "20200301"}], "brand_name": "Ibuprofen", "product_id": "68998-012_39f818d9-9278-c256-e063-6294a90a5e65", "dosage_form": "TABLET, COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68998-012", "generic_name": "Ibuprofen", "labeler_name": "MARC GLASSMAN, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA202312", "marketing_category": "ANDA", "marketing_start_date": "20200301", "listing_expiration_date": "20261231"}