Celecoxib

Product NDC
57582-211
11-digit product format
575820211
Labeler code
57582
Product ID
57582-211_30949e07-504d-43c2-b0d1-1c26dcaed176
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Tianjin Tianyao Pharmaceuticals Co., Ltd.
Application
ANDA207872
Marketing category
ANDA
Marketing start
2020-02-25
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
57582-211-01Celecoxib60 in 1 BOTTLECAPSULE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57582-211CELECOXIB (CELECOXIB) CAPSULE [TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. ]5Current NDC, Legacy NDC, 1 package rows20220706_76f9bcb7-0e94-485f-816d-61d4e1ed24e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN76f9bcb7-0e94-485f-816d-61d4e1ed24e05
205323celecoxib 200 MG Oral CapsulePSN76f9bcb7-0e94-485f-816d-61d4e1ed24e05
349514celecoxib 400 MG Oral CapsulePSN76f9bcb7-0e94-485f-816d-61d4e1ed24e05
686379celecoxib 50 MG Oral CapsulePSN76f9bcb7-0e94-485f-816d-61d4e1ed24e05
205322celecoxib 100 MG Oral CapsuleSCD76f9bcb7-0e94-485f-816d-61d4e1ed24e05
205323celecoxib 200 MG Oral CapsuleSCD76f9bcb7-0e94-485f-816d-61d4e1ed24e05
349514celecoxib 400 MG Oral CapsuleSCD76f9bcb7-0e94-485f-816d-61d4e1ed24e05
686379celecoxib 50 MG Oral CapsuleSCD76f9bcb7-0e94-485f-816d-61d4e1ed24e05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57582-211-015758202110160 CAPSULE in 1 BOTTLE (57582-211-01) 60 capsule2020-02-250000-00-00NoNoCurrent