Celecoxib

Product NDC
53217-156
11-digit product format
532170156
Labeler code
53217
Product ID
53217-156_b1418125-e23b-471e-acae-0295519300a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
NDA020998
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-12-10
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
100 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-156-01Celecoxib100 in 1 BOTTLECAPSULE1001
53217-156-30Celecoxib30 in 1 BOTTLECAPSULE301
53217-156-55Celecoxib500 in 1 BOTTLECAPSULE5001
53217-156-60Celecoxib60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-156-30EA - Each53217-156fcfc13aa-d1c8-4b3d-badb-1d4ec1c8a1a912015-10-02
53217-156-60EA - Each53217-15687a40caa-acd3-4dba-9b58-3f58b9470cdc12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELECOXIB CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELECOXIB CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELECOXIB CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LCELECOXIB CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELECOXIB CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELECOXIB CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECELECOXIB CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELECOXIB CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-156CELECOXIB CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20150329_41b4dd3f-844c-4f98-8a1c-6df13436b712.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN41b4dd3f-844c-4f98-8a1c-6df13436b7121
205323celecoxib 200 MG Oral CapsulePSN41b4dd3f-844c-4f98-8a1c-6df13436b7121
205322celecoxib 100 MG Oral CapsuleSCD41b4dd3f-844c-4f98-8a1c-6df13436b7121
205323celecoxib 200 MG Oral CapsuleSCD41b4dd3f-844c-4f98-8a1c-6df13436b7121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-156-0153217015601100 in 1 BOTTLEHistorical
53217-156-305321701563030 in 1 BOTTLEHistorical
53217-156-5553217015655500 in 1 BOTTLEHistorical
53217-156-605321701566060 in 1 BOTTLEHistorical