FDA.reportPublic FDA data

Celecoxib

Product NDC
72789-259
11-digit product format
727890259
Labeler code
72789
Product ID
72789-259_31bbf8f5-9205-ae15-e063-6394a90adb19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
72789-259-14Celecoxib14 in 1 BOTTLE, PLASTICCAPSULE1412
72789-259-30Celecoxib30 in 1 BOTTLE, PLASTICCAPSULE3012
72789-259-60Celecoxib60 in 1 BOTTLE, PLASTICCAPSULE6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-259-14EA - Each72789-25986a09961-a5a4-452e-9976-162139d7606312022-10-06
72789-259-30EA - Each72789-2593bfa4198-c6a5-4850-9724-1d6c5ae8047c12022-08-04
72789-259-60EA - Each72789-259aca7829b-cbf9-4ff4-8816-f9fffa8171e012023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-259CELECOXIB CAPSULE [PD-RX PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 3 package rows20250403_06076494-62ad-4f58-b8bb-7038fcfe3b12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN06076494-62ad-4f58-b8bb-7038fcfe3b1212
205323celecoxib 200 MG Oral CapsuleSCD06076494-62ad-4f58-b8bb-7038fcfe3b1212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-259-147278902591414 CAPSULE in 1 BOTTLE, PLASTIC (72789-259-14) 14 capsule2022-07-180000-00-00NoNoCurrent
72789-259-307278902593030 CAPSULE in 1 BOTTLE, PLASTIC (72789-259-30) 30 capsule2022-07-080000-00-00NoNoCurrent
72789-259-607278902596060 CAPSULE in 1 BOTTLE, PLASTIC (72789-259-60) 60 capsule2022-09-200000-00-00NoNoCurrent