FDA.reportPublic FDA data

Celecoxib

Product NDC
63187-643
11-digit product format
631870643
Labeler code
63187
Product ID
63187-643_87d8cb44-f135-4660-8988-ad81480a9308
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA200562
Marketing category
ANDA
Marketing start
2015-03-12
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
63187-643-30Celecoxib30 in 1 BOTTLECAPSULE306
63187-643-60Celecoxib60 in 1 BOTTLECAPSULE606
63187-643-90Celecoxib90 in 1 BOTTLECAPSULE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-643-60EA - Each63187-64316438d21-1557-4364-a2a9-67d381eaba1212016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-643CELECOXIB CAPSULE [PROFICIENT RX LP]6Current NDC, Legacy NDC, 3 package rows20231219_c529b321-38ed-434f-b76e-06902cdd40dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNc529b321-38ed-434f-b76e-06902cdd40dc6
205322celecoxib 100 MG Oral CapsuleSCDc529b321-38ed-434f-b76e-06902cdd40dc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-643-306318706433030 CAPSULE in 1 BOTTLE (63187-643-30) 30 capsule2018-12-010000-00-00NoNoCurrent
63187-643-606318706436060 CAPSULE in 1 BOTTLE (63187-643-60) 60 capsule2018-12-010000-00-00NoNoCurrent
63187-643-906318706439090 CAPSULE in 1 BOTTLE (63187-643-90) 90 capsule2018-12-010000-00-00NoNoCurrent