ibuprofen

Generic: ibuprofen

Labeler: sola pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler sola pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibuprofen 300 mg/1

Manufacturer
SOLA Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70512-794
Product ID 70512-794_3a6156f7-9a9c-01d8-e063-6394a90aa500
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202413
Listing Expiration 2026-12-31
Marketing Start 2025-02-14

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 70512794
Hyphenated Format 70512-794

Supplemental Identifiers

RxCUI
197804
UPC
0370512794903
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 ANDA202413 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (70512-794-90)
source: ndc

Packages (1)

70512-794-90 90 TABLET in 1 BOTTLE (70512-794-90)

Ingredients (1)

ibuprofen (300 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": "3a6156f7-9a9c-01d8-e063-6394a90aa500", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0370512794903"], "unii": ["WK2XYI10QM"], "rxcui": ["197804"], "spl_set_id": ["44fb0842-c34e-477e-96df-350cd5d6800e"], "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": ["SOLA Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (70512-794-90)", "package_ndc": "70512-794-90", "marketing_start_date": "20250214"}], "brand_name": "Ibuprofen", "product_id": "70512-794_3a6156f7-9a9c-01d8-e063-6394a90aa500", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70512-794", "generic_name": "ibuprofen", "labeler_name": "SOLA Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "300 mg/1"}], "application_number": "ANDA202413", "marketing_category": "ANDA", "marketing_start_date": "20250214", "listing_expiration_date": "20261231"}