ibuprofen

Generic: ibuprofen

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler ascend laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 600 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-320
Product ID 67877-320_c9772df6-21a8-4bd5-9fdd-b69f4687b449
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091625
Listing Expiration 2026-12-31
Marketing Start 2015-12-21

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 67877320
Hyphenated Format 67877-320

Supplemental Identifiers

RxCUI
197805 197806 197807
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 ANDA091625 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (67877-320-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (67877-320-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (67877-320-30)
  • 50 TABLET, FILM COATED in 1 BOTTLE (67877-320-50)
source: ndc

Packages (4)

67877-320-01 100 TABLET, FILM COATED in 1 BOTTLE (67877-320-01) 67877-320-05 500 TABLET, FILM COATED in 1 BOTTLE (67877-320-05) 67877-320-30 30 TABLET, FILM COATED in 1 BOTTLE (67877-320-30) 67877-320-50 50 TABLET, FILM COATED in 1 BOTTLE (67877-320-50)

Ingredients (1)

ibuprofen (600 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": "c9772df6-21a8-4bd5-9fdd-b69f4687b449", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197805", "197806", "197807"], "spl_set_id": ["9ce036ef-a22d-4fca-9a62-1b10978f7b26"], "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": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (67877-320-01)", "package_ndc": "67877-320-01", "marketing_start_date": "20151221"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (67877-320-05)", "package_ndc": "67877-320-05", "marketing_start_date": "20151221"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (67877-320-30)", "package_ndc": "67877-320-30", "marketing_start_date": "20151221"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (67877-320-50)", "package_ndc": "67877-320-50", "marketing_start_date": "20151221"}], "brand_name": "Ibuprofen", "product_id": "67877-320_c9772df6-21a8-4bd5-9fdd-b69f4687b449", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "67877-320", "generic_name": "Ibuprofen", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "600 mg/1"}], "application_number": "ANDA091625", "marketing_category": "ANDA", "marketing_start_date": "20151221", "listing_expiration_date": "20261231"}