FDA.reportPublic FDA data

Celecoxib

Product NDC
83301-0011
11-digit product format
833010011
Labeler code
83301
Product ID
83301-0011_4d7d9800-75a8-5017-e063-6294a90ac45a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Mullan Pharmaceutical Inc.
Application
ANDA210071
Marketing category
ANDA
Marketing start
2024-01-01
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
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, 686379

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
83301-0011-1Celecoxib100 in 1 BOTTLECAPSULE1003
83301-0011-2Celecoxib500 in 1 BOTTLECAPSULE5003
83301-0011-3Celecoxib30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83301-0011-1EA - Each83301-0011f892d2c0-443b-4ef6-bff5-4c32e3f1dfe412025-03-04
83301-0011-2EA - Each83301-0011d8085f29-1314-4207-8471-f4b25fe1253d12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83301-0011CELECOXIB CAPSULE [MULLAN PHARMACEUTICAL INC.]2Current NDC, 3 package rows20250425_643e177f-216d-4dfa-824a-7516a488304e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN643e177f-216d-4dfa-824a-7516a488304e3
205323celecoxib 200 MG Oral CapsulePSN643e177f-216d-4dfa-824a-7516a488304e3
686379celecoxib 50 MG Oral CapsulePSN643e177f-216d-4dfa-824a-7516a488304e3
205322celecoxib 100 MG Oral CapsuleSCD643e177f-216d-4dfa-824a-7516a488304e3
205323celecoxib 200 MG Oral CapsuleSCD643e177f-216d-4dfa-824a-7516a488304e3
686379celecoxib 50 MG Oral CapsuleSCD643e177f-216d-4dfa-824a-7516a488304e3
205322celecoxib 100 MG Oral CapsulePSN4b2ffbdb-1847-d93b-e063-6394a90a06f52
205322celecoxib 100 MG Oral CapsuleSCD4b2ffbdb-1847-d93b-e063-6394a90a06f52
205322celecoxib 100 MG Oral CapsulePSN7f20976d-bed3-4a06-9aaf-f5b5240e4ce31
205322celecoxib 100 MG Oral CapsuleSCD7f20976d-bed3-4a06-9aaf-f5b5240e4ce31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83301-0011-183301001101100 CAPSULE in 1 BOTTLE (83301-0011-1) 100 capsule2024-01-01NoNoCurrent
83301-0011-283301001102500 CAPSULE in 1 BOTTLE (83301-0011-2) 500 capsule2024-01-01NoNoCurrent
83301-0011-38330100110330 CAPSULE in 1 BOTTLE (83301-0011-3) 30 capsule2024-01-01NoNoCurrent