FDA.reportPublic FDA data

Celecoxib

Product NDC
69367-301
11-digit product format
693670301
Labeler code
69367
Product ID
69367-301_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
100 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
CELECOXIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322, 205323

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
cc117a7e-1ef6-4866-90a7-ce0d190eef9aProduct name120200925
827beb42-45f2-95b8-6aa3-f35174375422Product name920160429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-301-01Celecoxib100 in 1 BOTTLECAPSULE1006
69367-301-05Celecoxib500 in 1 BOTTLECAPSULE5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-301-01EA - Each69367-301864a61f1-c31b-4214-8290-5d756850eacf12021-06-02
69367-301-05EA - Each69367-3013afa43a2-1bbc-4b40-b1e7-cab016a2404d12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-301CELECOXIB 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
205322celecoxib 100 MG Oral CapsulePSNcb0be640-067e-4422-9bec-d5fa07175bd06
205323celecoxib 200 MG Oral CapsulePSNcb0be640-067e-4422-9bec-d5fa07175bd06
205322celecoxib 100 MG Oral CapsuleSCDcb0be640-067e-4422-9bec-d5fa07175bd06
205323celecoxib 200 MG Oral CapsuleSCDcb0be640-067e-4422-9bec-d5fa07175bd06
205322celecoxib 100 MG Oral CapsulePSNf5d0e5b9-97d8-42a4-a0a0-c09dde7008e65
205322celecoxib 100 MG Oral CapsuleSCDf5d0e5b9-97d8-42a4-a0a0-c09dde7008e65
205322celecoxib 100 MG Oral CapsulePSNf8fdcc56-7a53-9a42-e053-6394a90a48d52
205322celecoxib 100 MG Oral CapsuleSCDf8fdcc56-7a53-9a42-e053-6394a90a48d52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-301-0169367030101100 CAPSULE in 1 BOTTLE (69367-301-01) 100 capsule2020-12-210000-00-00NoNoCurrent
69367-301-0569367030105500 CAPSULE in 1 BOTTLE (69367-301-05) 500 capsule2020-12-210000-00-00NoNoCurrent