Celecoxib

Product NDC
0904-6503
11-digit product format
009046503
Labeler code
0904
Product ID
0904-6503_945b6833-914c-4ec8-a9fa-2384b6483ea9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA204197
Marketing category
ANDA
Marketing start
2015-06-25
Marketing end
2026-06-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Celecoxib

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322, 205323

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
0904-6503-61Celecoxib1 in 1 BLISTER PACKCAPSULE19
0904-6503-61Celecoxib100 in 1 CARTONCAPSULE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6503-61EA - Each0904-6503bce7b3a8-d461-464c-927a-a24b70c0668712015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
POVIDONE K12INACTIVE INGREDIENT333AG72FWJCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
SHELLACINACTIVE INGREDIENT46N107B71OCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6503CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]9Current NDC, Legacy NDC, 2 package rows20250316_370b2bb0-8fb7-4e42-8ec4-e14bae2c4a46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNa4bc991b-ed27-4f52-a4c7-3b83a1af173912
205323celecoxib 200 MG Oral CapsulePSNa4bc991b-ed27-4f52-a4c7-3b83a1af173912
205322celecoxib 100 MG Oral CapsuleSCDa4bc991b-ed27-4f52-a4c7-3b83a1af173912
205323celecoxib 200 MG Oral CapsuleSCDa4bc991b-ed27-4f52-a4c7-3b83a1af173912
205322celecoxib 100 MG Oral CapsulePSN370b2bb0-8fb7-4e42-8ec4-e14bae2c4a469
205323celecoxib 200 MG Oral CapsulePSN370b2bb0-8fb7-4e42-8ec4-e14bae2c4a469
205322celecoxib 100 MG Oral CapsuleSCD370b2bb0-8fb7-4e42-8ec4-e14bae2c4a469
205323celecoxib 200 MG Oral CapsuleSCD370b2bb0-8fb7-4e42-8ec4-e14bae2c4a469

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6503-6100904650361100 BLISTER PACK in 1 CARTON (0904-6503-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2015-06-252026-06-30NoNoCurrent