ibuprofen

Generic: ibuprofen

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler nucare pharmaceuticals,inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3589
Product ID 68071-3589_141b6717-62ab-4bfb-e063-6394a90a884d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209178
Listing Expiration 2026-12-31
Marketing Start 2018-02-16

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 680713589
Hyphenated Format 68071-3589

Supplemental Identifiers

RxCUI
197803
UPC
0368071358940
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 ANDA209178 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68071-3589-4) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

68071-3589-4 1 BOTTLE in 1 CARTON (68071-3589-4) / 120 mL in 1 BOTTLE

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": "141b6717-62ab-4bfb-e063-6394a90a884d", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0368071358940"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["141b7964-cce6-74e4-e063-6294a90af746"], "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": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68071-3589-4)  / 120 mL in 1 BOTTLE", "package_ndc": "68071-3589-4", "marketing_start_date": "20240320"}], "brand_name": "Ibuprofen", "product_id": "68071-3589_141b6717-62ab-4bfb-e063-6394a90a884d", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68071-3589", "generic_name": "Ibuprofen", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA209178", "marketing_category": "ANDA", "marketing_start_date": "20180216", "listing_expiration_date": "20261231"}