ibuprofen

Generic: ibuprofen

Labeler: granules india limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler granules india limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 400 mg/1

Manufacturer
Granules India Limited

Identifiers & Regulatory

Product NDC 62207-354
Product ID 62207-354_44dee7dd-17ff-8faa-e063-6294a90a6712
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091625
Listing Expiration 2026-12-31
Marketing Start 2015-09-21

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 62207354
Hyphenated Format 62207-354

Supplemental Identifiers

RxCUI
197805 197806 197807
UPC
0362207355544 0362207356541 0362207354547
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
  • 400 mg/1
source: ndc
Packaging
  • 50 TABLET, FILM COATED in 1 BOTTLE (62207-354-42)
  • 100 TABLET, FILM COATED in 1 BOTTLE (62207-354-43)
  • 500 TABLET, FILM COATED in 1 BOTTLE (62207-354-47)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (62207-354-49)
  • 30 TABLET, FILM COATED in 1 BOTTLE (62207-354-54)
source: ndc

Packages (5)

62207-354-42 50 TABLET, FILM COATED in 1 BOTTLE (62207-354-42) 62207-354-43 100 TABLET, FILM COATED in 1 BOTTLE (62207-354-43) 62207-354-47 500 TABLET, FILM COATED in 1 BOTTLE (62207-354-47) 62207-354-49 1000 TABLET, FILM COATED in 1 BOTTLE (62207-354-49) 62207-354-54 30 TABLET, FILM COATED in 1 BOTTLE (62207-354-54)

Ingredients (1)

ibuprofen (400 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": "44dee7dd-17ff-8faa-e063-6294a90a6712", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0362207355544", "0362207356541", "0362207354547"], "unii": ["WK2XYI10QM"], "rxcui": ["197805", "197806", "197807"], "spl_set_id": ["8804564c-9e1b-43c1-8b58-fd6ace645f00"], "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": ["Granules India Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (62207-354-42)", "package_ndc": "62207-354-42", "marketing_start_date": "20150921"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (62207-354-43)", "package_ndc": "62207-354-43", "marketing_start_date": "20150921"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (62207-354-47)", "package_ndc": "62207-354-47", "marketing_start_date": "20150921"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (62207-354-49)", "package_ndc": "62207-354-49", "marketing_start_date": "20150921"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62207-354-54)", "package_ndc": "62207-354-54", "marketing_start_date": "20150921"}], "brand_name": "Ibuprofen", "product_id": "62207-354_44dee7dd-17ff-8faa-e063-6294a90a6712", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "62207-354", "generic_name": "Ibuprofen", "labeler_name": "Granules India Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "400 mg/1"}], "application_number": "ANDA091625", "marketing_category": "ANDA", "marketing_start_date": "20150921", "listing_expiration_date": "20261231"}