ibuprofen

Generic: ibuprofen

Labeler: strides pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ibuprofen 400 mg/1

Manufacturer
Strides Pharma Inc.

Identifiers & Regulatory

Product NDC 42543-966
Product ID 42543-966_405918bc-44f0-4096-b11d-7b4ae81bc2f2
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 42543966
Hyphenated Format 42543-966

Supplemental Identifiers

RxCUI
197805 197806 197807
UPC
0342543966079 0342543965072 0342543964075
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 ANDA078329 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (42543-966-07)
source: ndc

Packages (1)

42543-966-07 500 TABLET, FILM COATED in 1 BOTTLE (42543-966-07)

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": "405918bc-44f0-4096-b11d-7b4ae81bc2f2", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0342543966079", "0342543965072", "0342543964075"], "unii": ["WK2XYI10QM"], "rxcui": ["197805", "197806", "197807"], "spl_set_id": ["2313f7c3-7291-48c8-b455-7cd41716fdb8"], "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": ["Strides Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (42543-966-07)", "package_ndc": "42543-966-07", "marketing_start_date": "20200821"}], "brand_name": "Ibuprofen", "product_id": "42543-966_405918bc-44f0-4096-b11d-7b4ae81bc2f2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "42543-966", "generic_name": "Ibuprofen", "labeler_name": "Strides Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "400 mg/1"}], "application_number": "ANDA078329", "marketing_category": "ANDA", "marketing_start_date": "20200821", "listing_expiration_date": "20261231"}