FDA.reportPublic FDA data

Celecoxib

Product NDC
71205-664
11-digit product format
712050664
Labeler code
71205
Product ID
71205-664_13262ab6-d121-4138-bcff-daf5b8972f83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA205129
Marketing category
ANDA
Marketing start
2020-12-03
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
71205-664-14Celecoxib14 in 1 BOTTLECAPSULE142
71205-664-30Celecoxib30 in 1 BOTTLECAPSULE302
71205-664-60Celecoxib60 in 1 BOTTLECAPSULE602
71205-664-90Celecoxib90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-664-14EA - Each71205-664d07ab341-0bb0-4eda-9b0e-8dfd3b793ce212023-08-08
71205-664-30EA - Each71205-664fa8d4436-4fbd-454b-9071-ce75643c537d12022-08-04
71205-664-60EA - Each71205-6641acd1139-1b66-44a0-a9cc-5cc2aef1a6f212022-08-04
71205-664-90EA - Each71205-664a3cc6cab-1993-41ef-89e7-139c49c0895112023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-664CELECOXIB CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 4 package rows20230506_b9a7f32c-8136-4f29-be6b-4d5e904ca0f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNb9a7f32c-8136-4f29-be6b-4d5e904ca0f12
205323celecoxib 200 MG Oral CapsuleSCDb9a7f32c-8136-4f29-be6b-4d5e904ca0f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-664-147120506641414 CAPSULE in 1 BOTTLE (71205-664-14) 14 capsule2023-04-27NoNoCurrent
71205-664-307120506643030 CAPSULE in 1 BOTTLE (71205-664-30) 30 capsule2022-05-250000-00-00NoNoCurrent
71205-664-607120506646060 CAPSULE in 1 BOTTLE (71205-664-60) 60 capsule2022-05-250000-00-00NoNoCurrent
71205-664-907120506649090 CAPSULE in 1 BOTTLE (71205-664-90) 90 capsule2022-05-250000-00-00NoNoCurrent