ibuprofen

Generic: ibuprofen

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

Drug Facts

Product Profile

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

ibuprofen 200 mg/1

Manufacturer
Granules India Limited

Identifiers & Regulatory

Product NDC 62207-395
Product ID 62207-395_f37b04a6-8c5f-0644-e053-2995a90a40a0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079174
Listing Expiration 2026-12-31
Marketing Start 2019-08-13

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 62207395
Hyphenated Format 62207-395

Supplemental Identifiers

RxCUI
310965
UPC
0362207396462
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 ANDA079174 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 24 TABLET in 1 BOTTLE (62207-395-41)
  • 50 TABLET in 1 BOTTLE (62207-395-42)
  • 100 TABLET in 1 BOTTLE (62207-395-43)
  • 250 TABLET in 1 BOTTLE (62207-395-46)
  • 500 TABLET in 1 BOTTLE (62207-395-47)
  • 750 TABLET in 1 BOTTLE (62207-395-48)
  • 1000 TABLET in 1 BOTTLE (62207-395-49)
  • 10 TABLET in 1 BOTTLE (62207-395-51)
source: ndc

Packages (8)

62207-395-41 24 TABLET in 1 BOTTLE (62207-395-41) 62207-395-42 50 TABLET in 1 BOTTLE (62207-395-42) 62207-395-43 100 TABLET in 1 BOTTLE (62207-395-43) 62207-395-46 250 TABLET in 1 BOTTLE (62207-395-46) 62207-395-47 500 TABLET in 1 BOTTLE (62207-395-47) 62207-395-48 750 TABLET in 1 BOTTLE (62207-395-48) 62207-395-49 1000 TABLET in 1 BOTTLE (62207-395-49) 62207-395-51 10 TABLET in 1 BOTTLE (62207-395-51)

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": "f37b04a6-8c5f-0644-e053-2995a90a40a0", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0362207396462"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["fd01353d-1d1d-42b5-9a03-575052189bf5"], "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": "24 TABLET in 1 BOTTLE (62207-395-41)", "package_ndc": "62207-395-41", "marketing_start_date": "20190813"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE (62207-395-42)", "package_ndc": "62207-395-42", "marketing_start_date": "20190813"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (62207-395-43)", "package_ndc": "62207-395-43", "marketing_start_date": "20190813"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (62207-395-46)", "package_ndc": "62207-395-46", "marketing_start_date": "20190813"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (62207-395-47)", "package_ndc": "62207-395-47", "marketing_start_date": "20190813"}, {"sample": false, "description": "750 TABLET in 1 BOTTLE (62207-395-48)", "package_ndc": "62207-395-48", "marketing_start_date": "20190813"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (62207-395-49)", "package_ndc": "62207-395-49", "marketing_start_date": "20190813"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (62207-395-51)", "package_ndc": "62207-395-51", "marketing_start_date": "20190813"}], "brand_name": "Ibuprofen", "product_id": "62207-395_f37b04a6-8c5f-0644-e053-2995a90a40a0", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "62207-395", "generic_name": "Ibuprofen", "labeler_name": "Granules India Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA079174", "marketing_category": "ANDA", "marketing_start_date": "20190813", "listing_expiration_date": "20261231"}