ibuprofen

Generic: ibuprofen

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler asclemed usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 800 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-848
Product ID 76420-848_2195e546-9f39-0130-e063-6294a90ad9c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202413
Listing Expiration 2026-12-31
Marketing Start 2024-05-23

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 76420848
Hyphenated Format 76420-848

Supplemental Identifiers

RxCUI
197805 197806 197807
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 ANDA202413 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76420-848-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (76420-848-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-848-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-848-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-848-90)
source: ndc

Packages (5)

76420-848-01 100 TABLET, FILM COATED in 1 BOTTLE (76420-848-01) 76420-848-05 500 TABLET, FILM COATED in 1 BOTTLE (76420-848-05) 76420-848-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-848-30) 76420-848-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-848-60) 76420-848-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-848-90)

Ingredients (1)

ibuprofen (800 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": "2195e546-9f39-0130-e063-6294a90ad9c3", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197805", "197806", "197807"], "spl_set_id": ["ca81671d-1ea8-4c67-802f-adb3a2f087cc"], "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": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76420-848-01)", "package_ndc": "76420-848-01", "marketing_start_date": "20240908"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (76420-848-05)", "package_ndc": "76420-848-05", "marketing_start_date": "20240908"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-848-30)", "package_ndc": "76420-848-30", "marketing_start_date": "20240908"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-848-60)", "package_ndc": "76420-848-60", "marketing_start_date": "20240908"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-848-90)", "package_ndc": "76420-848-90", "marketing_start_date": "20240908"}], "brand_name": "Ibuprofen", "product_id": "76420-848_2195e546-9f39-0130-e063-6294a90ad9c3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76420-848", "generic_name": "Ibuprofen", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "800 mg/1"}], "application_number": "ANDA202413", "marketing_category": "ANDA", "marketing_start_date": "20240523", "listing_expiration_date": "20261231"}