FDA.reportPublic FDA data

Celecoxib

Product NDC
71205-020
11-digit product format
712050020
Labeler code
71205
Product ID
71205-020_3923b0b2-c0f4-422a-b174-fa0bd0648a59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204519
Marketing category
ANDA
Marketing start
2015-12-01
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
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
CELECOXIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322

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
71205-020-30Celecoxib30 in 1 BOTTLECAPSULE302
71205-020-60Celecoxib60 in 1 BOTTLECAPSULE602
71205-020-90Celecoxib90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-020-60EA - Each71205-02060f08126-4856-449b-b7c3-102da8f8126012018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-020CELECOXIB CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20191101_7a234c0c-30a7-49f5-92a1-a1fc836ff9ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN7a234c0c-30a7-49f5-92a1-a1fc836ff9ae2
205322celecoxib 100 MG Oral CapsuleSCD7a234c0c-30a7-49f5-92a1-a1fc836ff9ae2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-020-307120500203030 CAPSULE in 1 BOTTLE (71205-020-30) 30 capsule2018-04-020000-00-00NoNoCurrent
71205-020-607120500206060 CAPSULE in 1 BOTTLE (71205-020-60) 60 capsule2018-04-020000-00-00NoNoCurrent
71205-020-907120500209090 CAPSULE in 1 BOTTLE (71205-020-90) 90 capsule2018-04-020000-00-00NoNoCurrent