Celecoxib

Product NDC
46708-267
11-digit product format
467080267
Labeler code
46708
Product ID
46708-267_c884ffd4-3a40-48a1-99b6-73b1ef9324b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA204519
Marketing category
ANDA
Marketing start
2015-08-22
Substance
CELECOXIB
Active strength
50 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
CELECOXIB50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322, 205323, 349514, 686379

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
46708-267-12Celecoxib80 in 1 CARTONCAPSULE804
46708-267-30Celecoxib30 in 1 BOTTLECAPSULE304
46708-267-60Celecoxib60 in 1 BOTTLECAPSULE604
46708-267-91Celecoxib1000 in 1 BOTTLECAPSULE10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-267CELECOXIB CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 4 package rows20230129_14e8d788-e44c-4a40-8678-25cf45fed477.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN14e8d788-e44c-4a40-8678-25cf45fed4774
205323celecoxib 200 MG Oral CapsulePSN14e8d788-e44c-4a40-8678-25cf45fed4774
349514celecoxib 400 MG Oral CapsulePSN14e8d788-e44c-4a40-8678-25cf45fed4774
686379celecoxib 50 MG Oral CapsulePSN14e8d788-e44c-4a40-8678-25cf45fed4774
205322celecoxib 100 MG Oral CapsuleSCD14e8d788-e44c-4a40-8678-25cf45fed4774
205323celecoxib 200 MG Oral CapsuleSCD14e8d788-e44c-4a40-8678-25cf45fed4774
349514celecoxib 400 MG Oral CapsuleSCD14e8d788-e44c-4a40-8678-25cf45fed4774
686379celecoxib 50 MG Oral CapsuleSCD14e8d788-e44c-4a40-8678-25cf45fed4774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-267-1046708026710100 CAPSULE in 1 CARTON (46708-267-10) 100 capsule2015-08-220000-00-00NoNoCurrent
46708-267-124670802671280 CAPSULE in 1 CARTON (46708-267-12) 80 capsule2015-08-220000-00-00NoNoCurrent
46708-267-304670802673030 CAPSULE in 1 BOTTLE (46708-267-30) 30 capsule2015-08-220000-00-00NoNoCurrent
46708-267-604670802676060 CAPSULE in 1 BOTTLE (46708-267-60) 60 capsule2015-08-220000-00-00NoNoCurrent
46708-267-91467080267911000 CAPSULE in 1 BOTTLE (46708-267-91) 1000 capsule2015-08-220000-00-00NoNoCurrent