FDA.reportPublic FDA data

CELECOXIB

Product NDC
60687-436
11-digit product format
606870436
Labeler code
60687
Product ID
60687-436_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
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
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
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
60687-436-01CELECOXIB100 in 1 CARTONCAPSULE1006
60687-436-11CELECOXIB1 in 1 BLISTER PACKCAPSULE16
60687-436-65CELECOXIB50 in 1 CARTONCAPSULE506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-436-01EA - Each60687-436554c77f2-964d-41a6-bcf8-b2d850e6d53312019-07-02
60687-436-11EA - Each60687-43647564b21-c0a9-4b94-80f2-4ff11ccd995b12019-07-02
60687-436-65EA - Each60687-4367304b3a7-c310-483e-aa15-3616afd8536512026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-436CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 3 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
60687-436-0160687043601100 BLISTER PACK in 1 CARTON (60687-436-01) / 1 CAPSULE in 1 BLISTER PACK (60687-436-11) 100 blister pack2019-07-100000-00-00NoNoCurrent
60687-436-11606870436111 in 1 BLISTER PACKHistorical
60687-436-656068704366550 BLISTER PACK in 1 CARTON (60687-436-65) / 1 CAPSULE in 1 BLISTER PACK (60687-436-11) 50 blister pack2026-02-01NoNoHistorical