Celecoxib

Product NDC
69367-302
11-digit product format
693670302
Labeler code
69367
Product ID
69367-302_98458883-6f96-4aa8-8feb-4d940b51c88d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA210071
Marketing category
ANDA
Marketing start
2020-12-21
Substance
CELECOXIB
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Celecoxib
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322, 205323

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
cc117a7e-1ef6-4866-90a7-ce0d190eef9aProduct name120200925
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
827beb42-45f2-95b8-6aa3-f35174375422Product name920160429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-302-01Celecoxib100 in 1 BOTTLECAPSULE1006
69367-302-05Celecoxib500 in 1 BOTTLECAPSULE5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-302-01EA - Each69367-302dbe63a8b-e207-4327-b3ce-a3ab3e225f2612021-06-02
69367-302-05EA - Each69367-302c0d91995-4834-4312-b191-41501f1d9f8512021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-302CELECOXIB CAPSULE [WESTMINSTER PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20241206_cb0be640-067e-4422-9bec-d5fa07175bd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNeca923da-59fa-da2e-e053-2a95a90a6a517
205323celecoxib 200 MG Oral CapsuleSCDeca923da-59fa-da2e-e053-2a95a90a6a517
205322celecoxib 100 MG Oral CapsulePSNcb0be640-067e-4422-9bec-d5fa07175bd06
205323celecoxib 200 MG Oral CapsulePSNcb0be640-067e-4422-9bec-d5fa07175bd06
205323celecoxib 200 MG Oral CapsulePSNc96509cc-47f4-44f8-9f7e-4e49cc3d53486
205322celecoxib 100 MG Oral CapsuleSCDcb0be640-067e-4422-9bec-d5fa07175bd06
205323celecoxib 200 MG Oral CapsuleSCDcb0be640-067e-4422-9bec-d5fa07175bd06
205323celecoxib 200 MG Oral CapsuleSCDc96509cc-47f4-44f8-9f7e-4e49cc3d53486
205323celecoxib 200 MG Oral CapsulePSN3a450db8-313c-4120-9b8e-58c956323fa44
205323celecoxib 200 MG Oral CapsuleSCD3a450db8-313c-4120-9b8e-58c956323fa44
205323celecoxib 200 MG Oral CapsulePSNb0839895-6a36-4e4f-9336-98632b60622a3
205323celecoxib 200 MG Oral CapsulePSN0de7a6f8-baba-1fd0-e063-6394a90ad4343
205323celecoxib 200 MG Oral CapsuleSCDb0839895-6a36-4e4f-9336-98632b60622a3
205323celecoxib 200 MG Oral CapsuleSCD0de7a6f8-baba-1fd0-e063-6394a90ad4343
205323celecoxib 200 MG Oral CapsulePSNa9749f00-0307-4842-a95b-9a8b4989df252
205323celecoxib 200 MG Oral CapsuleSCDa9749f00-0307-4842-a95b-9a8b4989df252
205323celecoxib 200 MG Oral CapsulePSN85b87dd2-c609-4d69-99eb-0acd852acdaf1
205323celecoxib 200 MG Oral CapsulePSN5250529a-6a03-78a1-e063-6294a90a47f91
205323celecoxib 200 MG Oral CapsulePSNdea035a6-dcf1-4b7d-8adc-a2f678b71fd91
205323celecoxib 200 MG Oral CapsulePSN1cbe21c0-3425-9a25-e063-6294a90a0d1d1
205323celecoxib 200 MG Oral CapsuleSCD85b87dd2-c609-4d69-99eb-0acd852acdaf1
205323celecoxib 200 MG Oral CapsuleSCD5250529a-6a03-78a1-e063-6294a90a47f91
205323celecoxib 200 MG Oral CapsuleSCD1cbe21c0-3425-9a25-e063-6294a90a0d1d1
205323celecoxib 200 MG Oral CapsuleSCDdea035a6-dcf1-4b7d-8adc-a2f678b71fd91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-302-0169367030201100 CAPSULE in 1 BOTTLE (69367-302-01) 100 capsule2020-12-210000-00-00NoNoCurrent
69367-302-0569367030205500 CAPSULE in 1 BOTTLE (69367-302-05) 500 capsule2020-12-210000-00-00NoNoCurrent