celecoxib

Product NDC
33342-155
11-digit product format
333420155
Labeler code
33342
Product ID
33342-155_bab34b9b-3e23-475d-a538-c0e3fe08be49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA204590
Marketing category
ANDA
Marketing start
2016-03-16
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
celecoxib
Listing expiration
2027-12-31

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
33342-155-09celecoxib60 in 1 BOTTLECAPSULE6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-155-09EA - Each33342-155f10a0b8a-0766-46e6-b0cc-2660158a9d9c12016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-155CELECOXIB CAPSULE [MACLEODS PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 1 package rows20250101_d14aecf5-16e9-459a-bda4-4ca8f290796a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNd14aecf5-16e9-459a-bda4-4ca8f290796a10
205323celecoxib 200 MG Oral CapsulePSNd14aecf5-16e9-459a-bda4-4ca8f290796a10
349514celecoxib 400 MG Oral CapsulePSNd14aecf5-16e9-459a-bda4-4ca8f290796a10
686379celecoxib 50 MG Oral CapsulePSNd14aecf5-16e9-459a-bda4-4ca8f290796a10
205322celecoxib 100 MG Oral CapsuleSCDd14aecf5-16e9-459a-bda4-4ca8f290796a10
205323celecoxib 200 MG Oral CapsuleSCDd14aecf5-16e9-459a-bda4-4ca8f290796a10
349514celecoxib 400 MG Oral CapsuleSCDd14aecf5-16e9-459a-bda4-4ca8f290796a10
686379celecoxib 50 MG Oral CapsuleSCDd14aecf5-16e9-459a-bda4-4ca8f290796a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-155-093334201550960 CAPSULE in 1 BOTTLE (33342-155-09) 60 capsule2016-03-160000-00-00NoNoCurrent