FDA.reportPublic FDA data

Celecoxib

Product NDC
83008-013
11-digit product format
830080013
Labeler code
83008
Product ID
83008-013_92c08da3-b8ec-4335-8c40-d1f1159a629d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA205129
Marketing category
ANDA
Marketing start
2023-04-25
Marketing end
2027-06-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Celecoxib

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205323

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
83008-013-30Celecoxib30 in 1 BOTTLECAPSULE303
83008-013-60Celecoxib60 in 1 BOTTLECAPSULE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83008-013-30EA - Each83008-01332b70f7a-a428-4c2d-9ae7-451e640e327c12023-08-08
83008-013-60EA - Each83008-013f76d7d76-68ef-44d3-a6d8-9343b06914d812023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83008-013CELECOXIB CAPSULE [QUALITY CARE PRODUCTS, LLC]3Current NDC, 2 package rows20241222_fcf49d7f-8319-4051-b7ac-fe063268b39b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNfcf49d7f-8319-4051-b7ac-fe063268b39b3
205323celecoxib 200 MG Oral CapsuleSCDfcf49d7f-8319-4051-b7ac-fe063268b39b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83008-013-308300800133030 CAPSULE in 1 BOTTLE (83008-013-30) 30 capsule2023-04-252027-06-30NoNoHistorical
83008-013-608300800136060 CAPSULE in 1 BOTTLE (83008-013-60) 60 capsule2023-04-252027-06-30NoNoHistorical