ibuprofen oral

Generic: ibuprofen oral

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

Drug Facts

Product Profile

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

ibuprofen 100 mg/5mL

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-1628
Product ID 68071-1628_1d4dcfbd-9377-6426-e063-6394a90aa935
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210602
Listing Expiration 2026-12-31
Marketing Start 2018-11-23

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 680711628
Hyphenated Format 68071-1628

Supplemental Identifiers

RxCUI
197803
UPC
0368071162844
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 oral (source: ndc)
Generic Name ibuprofen oral (source: ndc)
Application Number ANDA210602 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (68071-1628-4)
source: ndc

Packages (1)

68071-1628-4 118 mL in 1 BOTTLE (68071-1628-4)

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Ibuprofen Oral ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1d4dcfbd-9377-6426-e063-6394a90aa935", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0368071162844"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["84764eda-7446-5b16-e053-2991aa0abd7c"], "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": "118 mL in 1 BOTTLE (68071-1628-4)", "package_ndc": "68071-1628-4", "marketing_start_date": "20190319"}], "brand_name": "Ibuprofen Oral", "product_id": "68071-1628_1d4dcfbd-9377-6426-e063-6394a90aa935", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68071-1628", "generic_name": "Ibuprofen Oral", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen Oral", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA210602", "marketing_category": "ANDA", "marketing_start_date": "20181123", "listing_expiration_date": "20261231"}