FDA.reportPublic FDA data

Celecoxib

Product NDC
50090-6577
11-digit product format
500906577
Labeler code
50090
Product ID
50090-6577_793fd500-f266-42b4-9d5d-604d3a77cd2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210071
Marketing category
ANDA
Marketing start
2020-12-21
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
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
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
50090-6577-0Celecoxib30 in 1 BOTTLECAPSULE301
50090-6577-1Celecoxib60 in 1 BOTTLECAPSULE601
50090-6577-2Celecoxib90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6577-0EA - Each50090-65778d6ce4cf-f0f7-454e-8d99-3e7845f6e15912023-09-05
50090-6577-1EA - Each50090-6577b55a42bd-4604-453e-a7d3-c9c2db28ed3412023-09-05
50090-6577-2EA - Each50090-65770e9c9be7-d7a3-48b5-9a59-6b8a7c266aea12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6577CELECOXIB CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20230807_dea035a6-dcf1-4b7d-8adc-a2f678b71fd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNdea035a6-dcf1-4b7d-8adc-a2f678b71fd91
205323celecoxib 200 MG Oral CapsuleSCDdea035a6-dcf1-4b7d-8adc-a2f678b71fd91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6577-05009065770030 CAPSULE in 1 BOTTLE (50090-6577-0) 30 capsule2023-08-03NoNoCurrent
50090-6577-15009065770160 CAPSULE in 1 BOTTLE (50090-6577-1) 60 capsule2023-08-03NoNoCurrent
50090-6577-25009065770290 CAPSULE in 1 BOTTLE (50090-6577-2) 90 capsule2023-08-03NoNoCurrent