FDA.reportPublic FDA data

celecoxib

Product NDC
71205-027
11-digit product format
712050027
Labeler code
71205
Product ID
71205-027_9e0658ec-8ba6-4b80-b669-a8904b41fdfb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
71205-027-14celecoxib14 in 1 BOTTLECAPSULE146
71205-027-30celecoxib30 in 1 BOTTLECAPSULE306
71205-027-60celecoxib60 in 1 BOTTLECAPSULE606
71205-027-90celecoxib90 in 1 BOTTLECAPSULE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-027-14EA - Each71205-0274b4dba88-2ccf-48b0-a604-37923e10977d12022-03-09
71205-027-30EA - Each71205-02757cf554f-70cb-4d0a-9c53-e2ce0c841b6c12018-07-03
71205-027-60EA - Each71205-027ee9ebaf9-0d65-46f8-a664-ece4d200a80912018-08-13
71205-027-90EA - Each71205-027520c248c-ad29-45e5-b1de-28cee121bbb412021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-027CELECOXIB CAPSULE [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20220416_cbd2d6de-6f0d-4b69-8e27-a1fe08830ba5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNcbd2d6de-6f0d-4b69-8e27-a1fe08830ba56
205323celecoxib 200 MG Oral CapsuleSCDcbd2d6de-6f0d-4b69-8e27-a1fe08830ba56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-027-147120500271414 CAPSULE in 1 BOTTLE (71205-027-14) 14 capsule2022-01-050000-00-00NoNoCurrent
71205-027-307120500273030 CAPSULE in 1 BOTTLE (71205-027-30) 30 capsule2018-03-010000-00-00NoNoCurrent
71205-027-607120500276060 CAPSULE in 1 BOTTLE (71205-027-60) 60 capsule2018-05-010000-00-00NoNoCurrent
71205-027-907120500279090 CAPSULE in 1 BOTTLE (71205-027-90) 90 capsule2018-05-010000-00-00NoNoCurrent