MedPath

Celecoxib

Celecoxib 200mg Capsules

Approved
Approval ID

b3545cfb-97c3-b896-e053-2a95a90a15a0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 18, 2023

Manufacturers
FDA

Advanced Rx Pharmacy of Tennessee, LLC

DUNS: 117023142

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Celecoxib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code80425-0096
Application NumberANDA204590
Product Classification
M
Marketing Category
C73584
G
Generic Name
Celecoxib
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2023
FDA Product Classification

INGREDIENTS (1)

CELECOXIBActive
Quantity: 200 mg in 1 1
Code: JCX84Q7J1L
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Celecoxib - FDA Drug Approval Details