FDA.reportPublic FDA data

Celecoxib

Product NDC
76420-727
11-digit product format
764200727
Labeler code
76420
Product ID
76420-727_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
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, 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
76420-727-01Celecoxib1 in 1 BOTTLECAPSULE11
76420-727-05Celecoxib500 in 1 BOTTLECAPSULE5001
76420-727-07Celecoxib7 in 1 BOTTLECAPSULE71
76420-727-10Celecoxib100 in 1 BOTTLECAPSULE1001
76420-727-14Celecoxib14 in 1 BOTTLECAPSULE141
76420-727-20Celecoxib20 in 1 BOTTLECAPSULE201
76420-727-30Celecoxib30 in 1 BOTTLECAPSULE301
76420-727-60Celecoxib60 in 1 BOTTLECAPSULE601
76420-727-90Celecoxib90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-727-01EA - Each76420-7278b4ba966-ca33-4774-8446-27469ff8410e12025-03-04
76420-727-05EA - Each76420-727941d7514-ecbd-4fa2-ba11-894f2c674c7612025-03-04
76420-727-07EA - Each76420-727e4bec6f4-5c06-4d3c-9f4b-fd7a84df397812025-03-04
76420-727-10EA - Each76420-727abaa7346-7276-4de8-8ae8-ee689a416c8712025-03-04
76420-727-14EA - Each76420-727caa70b61-4f11-43f2-ae77-de8693b219e412025-03-04
76420-727-20EA - Each76420-727ea16df4e-77a7-4a28-92d8-eb3bf195c17012025-03-04
76420-727-30EA - Each76420-7270df2903b-a81b-4e9c-8798-e8f783c830dc12025-03-04
76420-727-60EA - Each76420-727dd36c394-f063-4490-b00d-6b905be1cc9e12025-03-04
76420-727-90EA - Each76420-727ea73a26a-55a7-411a-8ca9-e9698a9abaca12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-727CELECOXIB CAPSULE [ASCLEMED USA, INC.]1Current NDC, 9 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
76420-727-01764200727011 CAPSULE in 1 BOTTLE (76420-727-01) 1 capsule2024-05-10NoNoHistorical
76420-727-0576420072705500 CAPSULE in 1 BOTTLE (76420-727-05) 500 capsule2024-05-10NoNoHistorical
76420-727-07764200727077 CAPSULE in 1 BOTTLE (76420-727-07) 7 capsule2024-05-10NoNoHistorical
76420-727-1076420072710100 CAPSULE in 1 BOTTLE (76420-727-10) 100 capsule2024-05-10NoNoHistorical
76420-727-147642007271414 CAPSULE in 1 BOTTLE (76420-727-14) 14 capsule2024-05-10NoNoHistorical
76420-727-207642007272020 CAPSULE in 1 BOTTLE (76420-727-20) 20 capsule2024-05-10NoNoHistorical
76420-727-307642007273030 CAPSULE in 1 BOTTLE (76420-727-30) 30 capsule2024-05-10NoNoHistorical
76420-727-607642007276060 CAPSULE in 1 BOTTLE (76420-727-60) 60 capsule2024-05-10NoNoHistorical
76420-727-907642007279090 CAPSULE in 1 BOTTLE (76420-727-90) 90 capsule2024-05-10NoNoHistorical