FDA.reportPublic FDA data

CELECOXIB

Product NDC
50090-6380
11-digit product format
500906380
Labeler code
50090
Product ID
50090-6380_9817a8a2-182e-49dc-8c56-e21656eae510
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204776
Marketing category
ANDA
Marketing start
2018-06-01
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

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
50090-6380-0CELECOXIB30 in 1 BOTTLECAPSULE301
50090-6380-1CELECOXIB90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6380-0EA - Each50090-63809816eb72-e0d9-49bf-9d38-0ec02ac4589e12023-04-07
50090-6380-1EA - Each50090-638052e92ce1-6ae1-493d-ab9a-3ccf03f719e612023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6380CELECOXIB (CELECOXIB) CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20230302_c7a183dc-f4d5-483f-964c-f2745a3640ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNc7a183dc-f4d5-483f-964c-f2745a3640ad1
205322celecoxib 100 MG Oral CapsuleSCDc7a183dc-f4d5-483f-964c-f2745a3640ad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6380-05009063800030 CAPSULE in 1 BOTTLE (50090-6380-0) 30 capsule2023-02-23NoNoCurrent
50090-6380-15009063800190 CAPSULE in 1 BOTTLE (50090-6380-1) 90 capsule2023-02-23NoNoCurrent