FDA.reportPublic FDA data

Celecoxib 200 mg

Product NDC
63187-633
11-digit product format
631870633
Labeler code
63187
Product ID
63187-633_a97c2b4d-4a9b-4343-be08-aff7778679dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204519
Marketing category
ANDA
Marketing start
2015-11-24
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 200 mg
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-633-30Celecoxib 200 mg30 in 1 BOTTLECAPSULE302
63187-633-60Celecoxib 200 mg60 in 1 BOTTLECAPSULE602
63187-633-90Celecoxib 200 mg90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-633-30EA - Each63187-6333d2d5ec0-0197-4d92-9d43-7ae92db970fd12016-05-16
63187-633-60EA - Each63187-6331001c835-b308-467a-ae0c-9be4f9c6ab6c12016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-633CELECOXIB 200 MG (CELECOXIB) CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20191122_feee6a01-63f9-42c3-8bd8-ca713a08b36d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNfeee6a01-63f9-42c3-8bd8-ca713a08b36d2
205323celecoxib 200 MG Oral CapsuleSCDfeee6a01-63f9-42c3-8bd8-ca713a08b36d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-633-306318706333030 CAPSULE in 1 BOTTLE (63187-633-30) 30 capsule2015-11-240000-00-00NoNoCurrent
63187-633-606318706336060 CAPSULE in 1 BOTTLE (63187-633-60) 60 capsule2015-11-240000-00-00NoNoCurrent
63187-633-906318706339090 CAPSULE in 1 BOTTLE (63187-633-90) 90 capsule2015-11-240000-00-00NoNoCurrent