FDA.reportPublic FDA data

CELECOXIB

Product NDC
60687-447
11-digit product format
606870447
Labeler code
60687
Product ID
60687-447_499cb17d-c7e8-a21e-e063-6294a90a0b63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA204776
Marketing category
ANDA
Marketing start
2019-07-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CELECOXIB
Listing expiration
2027-12-31

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
60687-447-01CELECOXIB100 in 1 CARTONCAPSULE1006
60687-447-11CELECOXIB1 in 1 BLISTER PACKCAPSULE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-447-01EA - Each60687-4472b500ba8-d9bc-456d-b35f-e38cd017965e12019-07-02
60687-447-11EA - Each60687-447f1c0f6d5-613e-4a51-bda9-9eed01ba487d12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-447CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20240926_4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc76
205323celecoxib 200 MG Oral CapsulePSN4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc76
205322celecoxib 100 MG Oral CapsuleSCD4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc76
205323celecoxib 200 MG Oral CapsuleSCD4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-447-0160687044701100 BLISTER PACK in 1 CARTON (60687-447-01) / 1 CAPSULE in 1 BLISTER PACK (60687-447-11) 100 blister pack2019-07-100000-00-00NoNoCurrent
60687-447-11606870447111 in 1 BLISTER PACKHistorical