Celecoxib

Product NDC
29300-157
11-digit product format
293000157
Labeler code
29300
Product ID
29300-157_fbb9cff1-8a87-4280-a3f1-4d0560d65b0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA213301
Marketing category
ANDA
Marketing start
2021-01-12
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
29300-157-16Celecoxib60 in 1 BOTTLECAPSULE607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-157CELECOXIB CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]7Current NDC, Legacy NDC, 1 package rows20241222_0e8484a8-04a6-4be3-8c5c-1883b0490d53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN0e8484a8-04a6-4be3-8c5c-1883b0490d537
205323celecoxib 200 MG Oral CapsulePSN0e8484a8-04a6-4be3-8c5c-1883b0490d537
349514celecoxib 400 MG Oral CapsulePSN0e8484a8-04a6-4be3-8c5c-1883b0490d537
686379celecoxib 50 MG Oral CapsulePSN0e8484a8-04a6-4be3-8c5c-1883b0490d537
205322celecoxib 100 MG Oral CapsuleSCD0e8484a8-04a6-4be3-8c5c-1883b0490d537
205323celecoxib 200 MG Oral CapsuleSCD0e8484a8-04a6-4be3-8c5c-1883b0490d537
349514celecoxib 400 MG Oral CapsuleSCD0e8484a8-04a6-4be3-8c5c-1883b0490d537
686379celecoxib 50 MG Oral CapsuleSCD0e8484a8-04a6-4be3-8c5c-1883b0490d537

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-157-162930001571660 CAPSULE in 1 BOTTLE (29300-157-16) 60 capsule2021-08-010000-00-00NoNoCurrent