FDA.reportPublic FDA data

Celecoxib

Product NDC
76420-728
11-digit product format
764200728
Labeler code
76420
Product ID
76420-728_1814718c-03dc-471b-e063-6394a90a880e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA200562
Marketing category
ANDA
Marketing start
2015-03-12
Substance
CELECOXIB
Active strength
400 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
CELECOXIB400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322, 205323, 349514, 686379

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
76420-728-01Celecoxib1 in 1 BOTTLECAPSULE11
76420-728-07Celecoxib7 in 1 BOTTLECAPSULE71
76420-728-14Celecoxib14 in 1 BOTTLECAPSULE141
76420-728-20Celecoxib20 in 1 BOTTLECAPSULE201
76420-728-30Celecoxib30 in 1 BOTTLECAPSULE301
76420-728-60Celecoxib60 in 1 BOTTLECAPSULE601
76420-728-90Celecoxib90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-728-01EA - Each76420-728274974e4-9ca5-424a-8972-0059897724ff12025-03-04
76420-728-07EA - Each76420-7281d513b9f-7519-4ec8-b9b5-69ccf832b01212025-03-04
76420-728-14EA - Each76420-7289ccf5f4e-a81e-4f5a-b9c4-e1a192e03b2012025-03-04
76420-728-20EA - Each76420-7284d53b104-75ac-4b3b-89c3-95090cb822ff12025-03-04
76420-728-30EA - Each76420-728edc0a767-cf1c-44a6-97b2-8e1ce0cc470c12025-03-04
76420-728-60EA - Each76420-728db475aa5-4dd0-47c6-b8d8-f063f42bf88412025-03-04
76420-728-90EA - Each76420-7287828a6bd-8ef5-4fa8-9e36-33f544d5b65512025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-728CELECOXIB CAPSULE [ASCLEMED USA, INC.]1Current NDC, 7 package rows20240512_265b50cc-6d99-4ef8-8439-6792e1f21c68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN265b50cc-6d99-4ef8-8439-6792e1f21c681
205323celecoxib 200 MG Oral CapsulePSN265b50cc-6d99-4ef8-8439-6792e1f21c681
349514celecoxib 400 MG Oral CapsulePSN265b50cc-6d99-4ef8-8439-6792e1f21c681
686379celecoxib 50 MG Oral CapsulePSN265b50cc-6d99-4ef8-8439-6792e1f21c681
205322celecoxib 100 MG Oral CapsuleSCD265b50cc-6d99-4ef8-8439-6792e1f21c681
205323celecoxib 200 MG Oral CapsuleSCD265b50cc-6d99-4ef8-8439-6792e1f21c681
349514celecoxib 400 MG Oral CapsuleSCD265b50cc-6d99-4ef8-8439-6792e1f21c681
686379celecoxib 50 MG Oral CapsuleSCD265b50cc-6d99-4ef8-8439-6792e1f21c681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-728-01764200728011 CAPSULE in 1 BOTTLE (76420-728-01) 1 capsule2024-05-10NoNoHistorical
76420-728-07764200728077 CAPSULE in 1 BOTTLE (76420-728-07) 7 capsule2024-05-10NoNoHistorical
76420-728-147642007281414 CAPSULE in 1 BOTTLE (76420-728-14) 14 capsule2024-05-10NoNoHistorical
76420-728-207642007282020 CAPSULE in 1 BOTTLE (76420-728-20) 20 capsule2024-05-10NoNoHistorical
76420-728-307642007283030 CAPSULE in 1 BOTTLE (76420-728-30) 30 capsule2024-05-10NoNoHistorical
76420-728-607642007286060 CAPSULE in 1 BOTTLE (76420-728-60) 60 capsule2024-05-10NoNoHistorical
76420-728-907642007289090 CAPSULE in 1 BOTTLE (76420-728-90) 90 capsule2024-05-10NoNoHistorical