ibuprofen

Generic: ibuprofen

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 600 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-629
Product ID 71610-629_fb594a68-2160-4213-948a-02473c64c53c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078329
Listing Expiration 2026-12-31
Marketing Start 2020-08-21

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 71610629
Hyphenated Format 71610-629

Supplemental Identifiers

RxCUI
197806
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 ANDA078329 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-629-60)
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-629-80)
  • 270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-629-92)
source: ndc

Packages (3)

71610-629-60 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-629-60) 71610-629-80 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-629-80) 71610-629-92 270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-629-92)

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": "fb594a68-2160-4213-948a-02473c64c53c", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197806"], "spl_set_id": ["91723661-d0bb-4498-ac59-59bbdc334230"], "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": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-629-60)", "package_ndc": "71610-629-60", "marketing_start_date": "20211217"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-629-80)", "package_ndc": "71610-629-80", "marketing_start_date": "20211217"}, {"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-629-92)", "package_ndc": "71610-629-92", "marketing_start_date": "20220114"}], "brand_name": "Ibuprofen", "product_id": "71610-629_fb594a68-2160-4213-948a-02473c64c53c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "71610-629", "generic_name": "Ibuprofen", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "600 mg/1"}], "application_number": "ANDA078329", "marketing_category": "ANDA", "marketing_start_date": "20200821", "listing_expiration_date": "20261231"}