FDA.reportPublic FDA data

Celecoxib

Product NDC
76420-842
11-digit product format
764200842
Labeler code
76420
Product ID
76420-842_327a5fba-3c08-7bba-e063-6294a90a75e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA205129
Marketing category
ANDA
Marketing start
2020-12-03
Substance
CELECOXIB
Active strength
50 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
CELECOXIB50 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
76420-842-00Celecoxib1000 in 1 BOTTLECAPSULE10003
76420-842-01Celecoxib1 in 1 BOTTLECAPSULE13
76420-842-07Celecoxib7 in 1 BOTTLECAPSULE73
76420-842-14Celecoxib14 in 1 BOTTLECAPSULE143
76420-842-20Celecoxib20 in 1 BOTTLECAPSULE203
76420-842-30Celecoxib30 in 1 BOTTLECAPSULE303
76420-842-60Celecoxib60 in 1 BOTTLECAPSULE603
76420-842-90Celecoxib90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-842-00EA - Each76420-8426f49e29a-4dfe-401b-bfa8-8daac5540ee012025-08-11
76420-842-01EA - Each76420-8426fbc9779-1e82-407d-a65d-3308e9132dd812025-08-11
76420-842-07EA - Each76420-842a32e1b2c-743b-4c53-a455-3481c2d7edea12025-08-11
76420-842-14EA - Each76420-84223262eb0-3f85-4482-be52-5074bb0503b112025-08-11
76420-842-20EA - Each76420-8427da42924-db86-4fdd-8171-3973f5898da512025-08-11
76420-842-30EA - Each76420-8421dcf4c5b-7f64-494b-a614-ff8d04e9c76812025-08-11
76420-842-60EA - Each76420-8429a3e9575-39c0-4c46-8527-c649df0dcf4d12025-08-11
76420-842-90EA - Each76420-8420161d998-e504-48db-be81-f246b4e0e65612025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-842CELECOXIB CAPSULE [ASCLEMED USA, INC.]3Current NDC, 8 package rows20250413_5d0dcac1-237c-47aa-bcfb-50fa20b5b838.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN5d0dcac1-237c-47aa-bcfb-50fa20b5b8383
205323celecoxib 200 MG Oral CapsulePSN5d0dcac1-237c-47aa-bcfb-50fa20b5b8383
349514celecoxib 400 MG Oral CapsulePSN5d0dcac1-237c-47aa-bcfb-50fa20b5b8383
686379celecoxib 50 MG Oral CapsulePSN5d0dcac1-237c-47aa-bcfb-50fa20b5b8383
205322celecoxib 100 MG Oral CapsuleSCD5d0dcac1-237c-47aa-bcfb-50fa20b5b8383
205323celecoxib 200 MG Oral CapsuleSCD5d0dcac1-237c-47aa-bcfb-50fa20b5b8383
349514celecoxib 400 MG Oral CapsuleSCD5d0dcac1-237c-47aa-bcfb-50fa20b5b8383
686379celecoxib 50 MG Oral CapsuleSCD5d0dcac1-237c-47aa-bcfb-50fa20b5b8383

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-842-00764200842001000 CAPSULE in 1 BOTTLE (76420-842-00) 1000 capsule2024-08-17NoNoHistorical
76420-842-01764200842011 CAPSULE in 1 BOTTLE (76420-842-01) 1 capsule2024-08-17NoNoHistorical
76420-842-07764200842077 CAPSULE in 1 BOTTLE (76420-842-07) 7 capsule2024-08-17NoNoHistorical
76420-842-147642008421414 CAPSULE in 1 BOTTLE (76420-842-14) 14 capsule2024-08-17NoNoHistorical
76420-842-207642008422020 CAPSULE in 1 BOTTLE (76420-842-20) 20 capsule2024-08-17NoNoHistorical
76420-842-307642008423030 CAPSULE in 1 BOTTLE (76420-842-30) 30 capsule2024-08-17NoNoHistorical
76420-842-607642008426060 CAPSULE in 1 BOTTLE (76420-842-60) 60 capsule2024-08-17NoNoHistorical
76420-842-907642008429090 CAPSULE in 1 BOTTLE (76420-842-90) 90 capsule2024-08-17NoNoHistorical