FDA.reportPublic FDA data

celecoxib

Product NDC
13668-310
11-digit product format
136680310
Labeler code
13668
Product ID
13668-310_bff3a32b-43e3-46cd-b5c3-b691617fe4fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA207677
Marketing category
ANDA
Marketing start
2015-12-23
Substance
CELECOXIB
Active strength
400 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
CELECOXIB400 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
13668-310-01celecoxib100 in 1 BOTTLECAPSULE10013
13668-310-05celecoxib500 in 1 BOTTLECAPSULE50013
13668-310-30celecoxib30 in 1 BOTTLECAPSULE3013
13668-310-49celecoxib750 in 1 BOTTLECAPSULE75013
13668-310-60celecoxib60 in 1 BOTTLECAPSULE6013
13668-310-90celecoxib90 in 1 BOTTLECAPSULE9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-310-01EA - Each13668-310f18c7824-d682-4eb6-a7ae-a68d0c5c3c9b12017-08-11
13668-310-05EA - Each13668-3105b1ed02a-4aa8-4674-a959-559e5661696812017-07-07
13668-310-60EA - Each13668-310b85d1398-6722-4d91-a340-1f326c1a7e2c12017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-310CELECOXIB CAPSULE [TORRENT PHARMACEUTICALS LIMITED]13Current NDC, Legacy NDC, 6 package rows20241226_862698b6-2cc9-4374-992d-024beae6eba3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN862698b6-2cc9-4374-992d-024beae6eba313
205323celecoxib 200 MG Oral CapsulePSN862698b6-2cc9-4374-992d-024beae6eba313
349514celecoxib 400 MG Oral CapsulePSN862698b6-2cc9-4374-992d-024beae6eba313
686379celecoxib 50 MG Oral CapsulePSN862698b6-2cc9-4374-992d-024beae6eba313
205322celecoxib 100 MG Oral CapsuleSCD862698b6-2cc9-4374-992d-024beae6eba313
205323celecoxib 200 MG Oral CapsuleSCD862698b6-2cc9-4374-992d-024beae6eba313
349514celecoxib 400 MG Oral CapsuleSCD862698b6-2cc9-4374-992d-024beae6eba313
686379celecoxib 50 MG Oral CapsuleSCD862698b6-2cc9-4374-992d-024beae6eba313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-310-0113668031001100 CAPSULE in 1 BOTTLE (13668-310-01) 100 capsule2015-12-230000-00-00NoNoCurrent
13668-310-0513668031005500 CAPSULE in 1 BOTTLE (13668-310-05) 500 capsule2015-12-230000-00-00NoNoCurrent
13668-310-301366803103030 CAPSULE in 1 BOTTLE (13668-310-30) 30 capsule2015-12-230000-00-00NoNoCurrent
13668-310-4913668031049750 CAPSULE in 1 BOTTLE (13668-310-49) 750 capsule2015-12-230000-00-00NoNoCurrent
13668-310-601366803106060 CAPSULE in 1 BOTTLE (13668-310-60) 60 capsule2015-12-230000-00-00NoNoCurrent
13668-310-7413668031074100 CAPSULE in 1 CARTON (13668-310-74) 100 capsule2015-12-230000-00-00NoNoCurrent
13668-310-901366803109090 CAPSULE in 1 BOTTLE (13668-310-90) 90 capsule2015-12-230000-00-00NoNoCurrent