ibuprofen

Generic: ibuprofen

Labeler: taro pharmaceuticals u.s.a., inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler taro pharmaceuticals u.s.a., inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
TARO PHARMACEUTICALS U.S.A., INC.

Identifiers & Regulatory

Product NDC 51672-5321
Product ID 51672-5321_b7b5ccd2-1de9-4b93-b2bb-09bc540704fd
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211666
Listing Expiration 2026-12-31
Marketing Start 2024-08-15

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 516725321
Hyphenated Format 51672-5321

Supplemental Identifiers

RxCUI
197803
UPC
0351672532185
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 ANDA211666 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (51672-5321-1) / 240 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (51672-5321-8) / 120 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

51672-5321-1 1 BOTTLE, PLASTIC in 1 CARTON (51672-5321-1) / 240 mL in 1 BOTTLE, PLASTIC 51672-5321-8 1 BOTTLE, PLASTIC in 1 CARTON (51672-5321-8) / 120 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b7b5ccd2-1de9-4b93-b2bb-09bc540704fd", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0351672532185"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["9de61620-6750-4fb6-89a4-fe451ab8d99f"], "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": ["TARO PHARMACEUTICALS U.S.A., INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (51672-5321-1)  / 240 mL in 1 BOTTLE, PLASTIC", "package_ndc": "51672-5321-1", "marketing_start_date": "20241010"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (51672-5321-8)  / 120 mL in 1 BOTTLE, PLASTIC", "package_ndc": "51672-5321-8", "marketing_start_date": "20240815"}], "brand_name": "ibuprofen", "product_id": "51672-5321_b7b5ccd2-1de9-4b93-b2bb-09bc540704fd", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "51672-5321", "generic_name": "ibuprofen", "labeler_name": "TARO PHARMACEUTICALS U.S.A., INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA211666", "marketing_category": "ANDA", "marketing_start_date": "20240815", "listing_expiration_date": "20261231"}