FDA.reportPublic FDA data

celecoxib

Product NDC
76420-009
11-digit product format
764200009
Labeler code
76420
Product ID
76420-009_045987eb-8735-65e2-e063-6394a90a9699
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA204590
Marketing category
ANDA
Marketing start
2016-03-16
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
76420-009-01celecoxib1 in 1 BOTTLECAPSULE13
76420-009-07celecoxib7 in 1 BOTTLECAPSULE73
76420-009-14celecoxib14 in 1 BOTTLECAPSULE143
76420-009-20celecoxib20 in 1 BOTTLECAPSULE203
76420-009-30celecoxib30 in 1 BOTTLECAPSULE303
76420-009-60celecoxib60 in 1 BOTTLECAPSULE603
76420-009-90celecoxib90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-009-01EA - Each76420-009da411d70-e3cf-493e-84bc-f5e5dfb73a7412022-09-12
76420-009-07EA - Each76420-0091a18ca48-be71-4c09-8f8a-9cdcd52f5d7b12022-09-12
76420-009-30EA - Each76420-009ab296018-0f2d-4c05-997e-14bb7be72a0a12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-009CELECOXIB CAPSULE [ASCLEMED USA, INC.]3Current NDC, Legacy NDC, 7 package rows20230906_2a926010-08e1-44dd-bc6d-ed15374bd0d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN2a926010-08e1-44dd-bc6d-ed15374bd0d33
205323celecoxib 200 MG Oral CapsuleSCD2a926010-08e1-44dd-bc6d-ed15374bd0d33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-009-01764200009011 CAPSULE in 1 BOTTLE (76420-009-01) 1 capsule2020-01-180000-00-00NoNoCurrent
76420-009-07764200009077 CAPSULE in 1 BOTTLE (76420-009-07) 7 capsule2020-01-180000-00-00NoNoCurrent
76420-009-147642000091414 CAPSULE in 1 BOTTLE (76420-009-14) 14 capsule2023-09-02NoNoHistorical
76420-009-207642000092020 CAPSULE in 1 BOTTLE (76420-009-20) 20 capsule2023-09-02NoNoHistorical
76420-009-307642000093030 CAPSULE in 1 BOTTLE (76420-009-30) 30 capsule2020-01-180000-00-00NoNoCurrent
76420-009-607642000096060 CAPSULE in 1 BOTTLE (76420-009-60) 60 capsule2020-06-040000-00-00NoNoCurrent
76420-009-907642000099090 CAPSULE in 1 BOTTLE (76420-009-90) 90 capsule2023-09-02NoNoHistorical