FDA.reportPublic FDA data

CELECOXIB

Product NDC
51655-437
11-digit product format
516550437
Labeler code
51655
Product ID
51655-437_4b43d8e7-a5d3-238d-e063-6294a90a33dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA204776
Marketing category
ANDA
Marketing start
2020-09-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CELECOXIB
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205323

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-437-252026-01-29C16284748780-149896155-a831-586f-e063-e6dba90add90These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
51655-437-262026-01-29C16284748780-149896155-a831-586f-e063-e6dba90add90These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
51655-437-522026-01-29C16284748780-149896155-a831-586f-e063-e6dba90add90These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
51655-437-842026-01-29C16284748780-149896155-a831-586f-e063-e6dba90add90These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-437-25CELECOXIB60 in 1 BOTTLE, PLASTICCAPSULE604
51655-437-26CELECOXIB90 in 1 BOTTLE, PLASTICCAPSULE904
51655-437-52CELECOXIB30 in 1 BOTTLE, PLASTICCAPSULE304
51655-437-84CELECOXIB14 in 1 BOTTLE, PLASTICCAPSULE144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-437CELECOXIB CAPSULE [NORTHWIND PHARMACEUTICALS]1Current NDC, 4 package rows20230328_dac05189-4acf-d6bb-e053-2a95a90a46a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNdac05189-4acf-d6bb-e053-2a95a90a46a94
205323celecoxib 200 MG Oral CapsuleSCDdac05189-4acf-d6bb-e053-2a95a90a46a94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-437-255165504372560 CAPSULE in 1 BOTTLE, PLASTIC (51655-437-25) 60 capsule2021-01-28NoNoCurrent
51655-437-265165504372690 CAPSULE in 1 BOTTLE, PLASTIC (51655-437-26) 90 capsule2021-05-18NoNoCurrent
51655-437-525165504375230 CAPSULE in 1 BOTTLE, PLASTIC (51655-437-52) 30 capsule2021-05-21NoNoCurrent
51655-437-845165504378414 CAPSULE in 1 BOTTLE, PLASTIC (51655-437-84) 14 capsule2020-09-28NoNoCurrent