FDA.reportPublic FDA data

celecoxib

Product NDC
71335-0936
11-digit product format
713350936
Labeler code
71335
Product ID
71335-0936_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
100 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
CELECOXIB100 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
71335-0936-1celecoxib30 in 1 BOTTLECAPSULE307
71335-0936-2celecoxib20 in 1 BOTTLECAPSULE207
71335-0936-3celecoxib60 in 1 BOTTLECAPSULE607
71335-0936-4celecoxib90 in 1 BOTTLECAPSULE907
71335-0936-5celecoxib120 in 1 BOTTLECAPSULE1207
71335-0936-6celecoxib14 in 1 BOTTLECAPSULE147
71335-0936-7celecoxib10 in 1 BOTTLECAPSULE107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0936-1EA - Each71335-0936bc2efac3-f992-4050-86fd-e1407ae106e712021-11-09
71335-0936-3EA - Each71335-09367a4a8413-44e7-4f94-8a17-1bbca14cc4e812021-11-09
71335-0936-4EA - Each71335-09363c7e0e28-f2b0-4915-88d3-a892eda39d1912021-11-09
71335-0936-5EA - Each71335-09362be13cf1-acd0-4f12-82ec-35469e7a323212021-11-09
71335-0936-6EA - Each71335-09369c1b922d-9fdc-4a59-a925-0f4179b29adc12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0936CELECOXIB CAPSULE [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 7 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
71335-0936-17133509360130 CAPSULE in 1 BOTTLE (71335-0936-1) 30 capsule2018-08-290000-00-00NoNoCurrent
71335-0936-27133509360220 CAPSULE in 1 BOTTLE (71335-0936-2) 20 capsule2018-08-290000-00-00NoNoCurrent
71335-0936-37133509360360 CAPSULE in 1 BOTTLE (71335-0936-3) 60 capsule2018-08-290000-00-00NoNoCurrent
71335-0936-47133509360490 CAPSULE in 1 BOTTLE (71335-0936-4) 90 capsule2018-08-290000-00-00NoNoCurrent
71335-0936-571335093605120 CAPSULE in 1 BOTTLE (71335-0936-5) 120 capsule2018-08-290000-00-00NoNoCurrent
71335-0936-67133509360614 CAPSULE in 1 BOTTLE (71335-0936-6) 14 capsule2018-08-290000-00-00NoNoCurrent
71335-0936-77133509360710 CAPSULE in 1 BOTTLE (71335-0936-7) 10 capsule2018-08-29NoNoHistorical