FDA.reportPublic FDA data

Celecoxib

Product NDC
71205-055
11-digit product format
712050055
Labeler code
71205
Product ID
71205-055_4d79a70c-65fe-42e1-b57b-26c9c433e501
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
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
71205-055-30Celecoxib30 in 1 BOTTLECAPSULE303
71205-055-60Celecoxib60 in 1 BOTTLECAPSULE603
71205-055-90Celecoxib90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-055-30EA - Each71205-0553a466bcc-ed11-4fa6-b4c3-4f96cec61fc612018-08-13
71205-055-60EA - Each71205-05507010fdb-1f3f-4e5d-9d5d-540760ca29c112018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-055CELECOXIB CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191030_c787b0ab-77ab-4f7e-9fea-be2a0085020a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNc787b0ab-77ab-4f7e-9fea-be2a0085020a3
205323celecoxib 200 MG Oral CapsuleSCDc787b0ab-77ab-4f7e-9fea-be2a0085020a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-055-307120500553030 CAPSULE in 1 BOTTLE (71205-055-30) 30 capsule2018-06-010000-00-00NoNoCurrent
71205-055-607120500556060 CAPSULE in 1 BOTTLE (71205-055-60) 60 capsule2018-06-010000-00-00NoNoCurrent
71205-055-907120500559090 CAPSULE in 1 BOTTLE (71205-055-90) 90 capsule2018-06-010000-00-00NoNoCurrent