FDA.reportPublic FDA data

celecoxib

Product NDC
71335-0868
11-digit product format
713350868
Labeler code
71335
Product ID
71335-0868_73a78c98-7752-4bdf-802d-99e9887b4c9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204590
Marketing category
ANDA
Marketing start
2016-03-16
Substance
CELECOXIB
Active strength
200 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
CELECOXIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322, 205323

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
71335-0868-0celecoxib15 in 1 BOTTLECAPSULE157
71335-0868-1celecoxib30 in 1 BOTTLECAPSULE307
71335-0868-2celecoxib60 in 1 BOTTLECAPSULE607
71335-0868-3celecoxib90 in 1 BOTTLECAPSULE907
71335-0868-4celecoxib14 in 1 BOTTLECAPSULE147
71335-0868-5celecoxib20 in 1 BOTTLECAPSULE207
71335-0868-6celecoxib10 in 1 BOTTLECAPSULE107
71335-0868-7celecoxib180 in 1 BOTTLECAPSULE1807
71335-0868-8celecoxib28 in 1 BOTTLECAPSULE287
71335-0868-9celecoxib56 in 1 BOTTLECAPSULE567

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0868-1EA - Each71335-086839e47647-cc98-4bbf-9b3d-93e4f1bc438812019-03-12
71335-0868-2EA - Each71335-0868cc5a05e7-fbf3-48d5-a5d7-686d603aa0ab12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0868CELECOXIB CAPSULE [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 10 package rows20250223_ac5c0d72-1bb3-4065-b2f4-5516b0869775.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNac5c0d72-1bb3-4065-b2f4-5516b08697757
205323celecoxib 200 MG Oral CapsulePSNac5c0d72-1bb3-4065-b2f4-5516b08697757
205322celecoxib 100 MG Oral CapsuleSCDac5c0d72-1bb3-4065-b2f4-5516b08697757
205323celecoxib 200 MG Oral CapsuleSCDac5c0d72-1bb3-4065-b2f4-5516b08697757

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0868-07133508680015 CAPSULE in 1 BOTTLE (71335-0868-0) 15 capsule2018-07-050000-00-00NoNoCurrent
71335-0868-17133508680130 CAPSULE in 1 BOTTLE (71335-0868-1) 30 capsule2018-07-050000-00-00NoNoCurrent
71335-0868-27133508680260 CAPSULE in 1 BOTTLE (71335-0868-2) 60 capsule2018-07-050000-00-00NoNoCurrent
71335-0868-37133508680390 CAPSULE in 1 BOTTLE (71335-0868-3) 90 capsule2018-07-050000-00-00NoNoCurrent
71335-0868-47133508680414 CAPSULE in 1 BOTTLE (71335-0868-4) 14 capsule2018-07-050000-00-00NoNoCurrent
71335-0868-57133508680520 CAPSULE in 1 BOTTLE (71335-0868-5) 20 capsule2018-07-050000-00-00NoNoCurrent
71335-0868-67133508680610 CAPSULE in 1 BOTTLE (71335-0868-6) 10 capsule2018-07-050000-00-00NoNoCurrent
71335-0868-771335086807180 CAPSULE in 1 BOTTLE (71335-0868-7) 180 capsule2018-07-050000-00-00NoNoCurrent
71335-0868-87133508680828 CAPSULE in 1 BOTTLE (71335-0868-8) 28 capsule2018-07-050000-00-00NoNoCurrent
71335-0868-97133508680956 CAPSULE in 1 BOTTLE (71335-0868-9) 56 capsule2018-07-050000-00-00NoNoCurrent