FDA.reportPublic FDA data

Celecoxib

Product NDC
76420-714
11-digit product format
764200714
Labeler code
76420
Product ID
76420-714_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
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
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
76420-714-01Celecoxib1 in 1 BOTTLECAPSULE11
76420-714-05Celecoxib500 in 1 BOTTLECAPSULE5001
76420-714-07Celecoxib7 in 1 BOTTLECAPSULE71
76420-714-10Celecoxib100 in 1 BOTTLECAPSULE1001
76420-714-14Celecoxib14 in 1 BOTTLECAPSULE141
76420-714-20Celecoxib20 in 1 BOTTLECAPSULE201
76420-714-30Celecoxib30 in 1 BOTTLECAPSULE301
76420-714-60Celecoxib60 in 1 BOTTLECAPSULE601
76420-714-90Celecoxib90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-714-01EA - Each76420-71408d63fc8-f970-44ba-acb4-7ee8875bd9db12025-03-04
76420-714-05EA - Each76420-714004c99b4-255b-463e-a2fd-e276d933fa7312025-03-04
76420-714-07EA - Each76420-7144de10173-fb83-40d7-9286-9f70ba3bae0512025-03-04
76420-714-10EA - Each76420-714d27f8648-bb2a-4328-9368-fbd6f151839f12025-03-04
76420-714-14EA - Each76420-71499e473e8-122c-48c0-b0bc-1d22d40a872d12025-03-04
76420-714-20EA - Each76420-7140104270f-2bc5-49dc-a7bd-67209829406112025-03-04
76420-714-30EA - Each76420-714cb32e021-4e3b-4c0c-b7f4-47b8944f8bef12025-03-04
76420-714-60EA - Each76420-714df791211-324d-4066-ab23-27c7918375da12025-03-04
76420-714-90EA - Each76420-714fb0c10aa-980d-4c27-9c69-c2580f868b8f12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-714CELECOXIB 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
76420-714-01764200714011 CAPSULE in 1 BOTTLE (76420-714-01) 1 capsule2024-05-10NoNoHistorical
76420-714-0576420071405500 CAPSULE in 1 BOTTLE (76420-714-05) 500 capsule2024-05-10NoNoHistorical
76420-714-07764200714077 CAPSULE in 1 BOTTLE (76420-714-07) 7 capsule2024-05-10NoNoHistorical
76420-714-1076420071410100 CAPSULE in 1 BOTTLE (76420-714-10) 100 capsule2024-05-10NoNoHistorical
76420-714-147642007141414 CAPSULE in 1 BOTTLE (76420-714-14) 14 capsule2024-05-10NoNoHistorical
76420-714-207642007142020 CAPSULE in 1 BOTTLE (76420-714-20) 20 capsule2024-05-10NoNoHistorical
76420-714-307642007143030 CAPSULE in 1 BOTTLE (76420-714-30) 30 capsule2024-05-10NoNoHistorical
76420-714-607642007146060 CAPSULE in 1 BOTTLE (76420-714-60) 60 capsule2024-05-10NoNoHistorical
76420-714-907642007149090 CAPSULE in 1 BOTTLE (76420-714-90) 90 capsule2024-05-10NoNoHistorical