FDA.reportPublic FDA data

CELECOXIB

Product NDC
63187-301
11-digit product format
631870301
Labeler code
63187
Product ID
63187-301_2680eafe-f0cd-481e-830f-51b249135bdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207446
Marketing category
ANDA
Marketing start
2015-09-23
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

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
63187-301-30CELECOXIB30 in 1 BOTTLECAPSULE303
63187-301-60CELECOXIB60 in 1 BOTTLECAPSULE603
63187-301-90CELECOXIB90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-301-60EA - Each63187-301024f9082-7f0d-4dfc-887c-d864acd6228e12016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-301CELECOXIB CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20210116_c91e5933-1798-4096-9f08-fb1200e154e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNc91e5933-1798-4096-9f08-fb1200e154e13
205322celecoxib 100 MG Oral CapsuleSCDc91e5933-1798-4096-9f08-fb1200e154e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-301-306318703013030 CAPSULE in 1 BOTTLE (63187-301-30) 30 capsule2016-05-020000-00-00NoNoCurrent
63187-301-606318703016060 CAPSULE in 1 BOTTLE (63187-301-60) 60 capsule2016-05-020000-00-00NoNoCurrent
63187-301-906318703019090 CAPSULE in 1 BOTTLE (63187-301-90) 90 capsule2016-05-020000-00-00NoNoCurrent