celecoxib

Generic: celecoxib

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name celecoxib
Generic Name celecoxib
Labeler westminster pharmaceuticals, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

celecoxib 100 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-301
Product ID 69367-301_98458883-6f96-4aa8-8feb-4d940b51c88d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210071
Listing Expiration 2026-12-31
Marketing Start 2020-12-21

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 69367301
Hyphenated Format 69367-301

Supplemental Identifiers

RxCUI
205322 205323
UPC
0369367301053
UNII
JCX84Q7J1L
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 celecoxib (source: ndc)
Generic Name celecoxib (source: ndc)
Application Number ANDA210071 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (69367-301-01)
  • 500 CAPSULE in 1 BOTTLE (69367-301-05)
source: ndc

Packages (2)

69367-301-01 100 CAPSULE in 1 BOTTLE (69367-301-01) 69367-301-05 500 CAPSULE in 1 BOTTLE (69367-301-05)

Ingredients (1)

celecoxib (100 mg/1)

Linked Drug Pages (1)

Celecoxib ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "98458883-6f96-4aa8-8feb-4d940b51c88d", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0369367301053"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322", "205323"], "spl_set_id": ["cb0be640-067e-4422-9bec-d5fa07175bd0"], "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": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (69367-301-01)", "package_ndc": "69367-301-01", "marketing_start_date": "20201221"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (69367-301-05)", "package_ndc": "69367-301-05", "marketing_start_date": "20201221"}], "brand_name": "Celecoxib", "product_id": "69367-301_98458883-6f96-4aa8-8feb-4d940b51c88d", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69367-301", "generic_name": "Celecoxib", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Celecoxib", "active_ingredients": [{"name": "CELECOXIB", "strength": "100 mg/1"}], "application_number": "ANDA210071", "marketing_category": "ANDA", "marketing_start_date": "20201221", "listing_expiration_date": "20261231"}