ibuprofen

Generic: ibuprofen

Labeler: a-s medication solutions
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler a-s medication solutions
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7653
Product ID 50090-7653_65d7cba1-ee25-42e5-908f-a0e1e3416914
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 500907653
Hyphenated Format 50090-7653

Supplemental Identifiers

RxCUI
197803
UNII
WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

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 (50090-7653-0) / 120 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

50090-7653-0 1 BOTTLE, PLASTIC in 1 CARTON (50090-7653-0) / 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": "65d7cba1-ee25-42e5-908f-a0e1e3416914", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["7d4ba8be-df59-4a21-8850-8a59bf72b604"], "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": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50090-7653-0)  / 120 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50090-7653-0", "marketing_start_date": "20250909"}], "brand_name": "ibuprofen", "product_id": "50090-7653_65d7cba1-ee25-42e5-908f-a0e1e3416914", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50090-7653", "generic_name": "ibuprofen", "labeler_name": "A-S Medication Solutions", "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"}