ibuprofen

Generic: ibuprofen

Labeler: shield pharmaceuticals corp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler shield pharmaceuticals corp
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Shield Pharmaceuticals Corp

Identifiers & Regulatory

Product NDC 83059-0019
Product ID 83059-0019_458bacca-6d17-a7fc-e063-6294a90ab9b7
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207095
Listing Expiration 2026-12-31
Marketing Start 2024-01-25

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 830590019
Hyphenated Format 83059-0019

Supplemental Identifiers

RxCUI
310965
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 ANDA207095 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (83059-0019-3) / 30 TABLET, COATED in 1 BOTTLE
source: ndc

Packages (1)

83059-0019-3 1 BOTTLE in 1 CARTON (83059-0019-3) / 30 TABLET, COATED in 1 BOTTLE

Ingredients (1)

ibuprofen (200 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": "458bacca-6d17-a7fc-e063-6294a90ab9b7", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["25f9531b-e674-4c72-af42-ea0ad0a4a706"], "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": ["Shield Pharmaceuticals Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (83059-0019-3)  / 30 TABLET, COATED in 1 BOTTLE", "package_ndc": "83059-0019-3", "marketing_start_date": "20240125"}], "brand_name": "Ibuprofen", "product_id": "83059-0019_458bacca-6d17-a7fc-e063-6294a90ab9b7", "dosage_form": "TABLET, COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "83059-0019", "generic_name": "Ibuprofen", "labeler_name": "Shield Pharmaceuticals Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA207095", "marketing_category": "ANDA", "marketing_start_date": "20240125", "listing_expiration_date": "20261231"}