FDA.reportPublic FDA data

Celecoxib

Product NDC
71610-584
11-digit product format
716100584
Labeler code
71610
Product ID
71610-584_b3ea8ff0-0539-46fc-9ab6-aa6e8cb72549
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA205129
Marketing category
ANDA
Marketing start
2021-04-15
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
71610-584-30Celecoxib30 in 1 BOTTLECAPSULE301
71610-584-53Celecoxib60 in 1 BOTTLECAPSULE601
71610-584-60Celecoxib90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-584-30EA - Each71610-584e725f734-3910-4b48-8492-0539021a16ea12021-09-07
71610-584-53EA - Each71610-584d261eb22-8152-43a7-9693-8e7b167ad50812021-09-07
71610-584-60EA - Each71610-584158065d0-8c13-4812-84c7-38f222b1b31912021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-584CELECOXIB CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20210810_d258e065-e9a6-44e2-89c9-6892d771d9d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNd258e065-e9a6-44e2-89c9-6892d771d9d31
205323celecoxib 200 MG Oral CapsuleSCDd258e065-e9a6-44e2-89c9-6892d771d9d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-584-307161005843030 CAPSULE in 1 BOTTLE (71610-584-30) 30 capsule2021-07-200000-00-00NoNoCurrent
71610-584-537161005845360 CAPSULE in 1 BOTTLE (71610-584-53) 60 capsule2021-07-200000-00-00NoNoCurrent
71610-584-607161005846090 CAPSULE in 1 BOTTLE (71610-584-60) 90 capsule2021-07-200000-00-00NoNoCurrent