FDA.reportPublic FDA data

Celecoxib

Product NDC
76420-845
11-digit product format
764200845
Labeler code
76420
Product ID
76420-845_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
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
76420-845-01Celecoxib1 in 1 BOTTLECAPSULE13
76420-845-05Celecoxib500 in 1 BOTTLECAPSULE5003
76420-845-07Celecoxib7 in 1 BOTTLECAPSULE73
76420-845-14Celecoxib14 in 1 BOTTLECAPSULE143
76420-845-20Celecoxib20 in 1 BOTTLECAPSULE203
76420-845-30Celecoxib30 in 1 BOTTLECAPSULE303
76420-845-60Celecoxib60 in 1 BOTTLECAPSULE603
76420-845-90Celecoxib90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-845-01EA - Each76420-84545e0b675-7996-43a6-aaf4-b889882b041b12025-08-11
76420-845-05EA - Each76420-845030eeeeb-d0be-44cc-8e44-4bbfcba57dcc12025-08-11
76420-845-07EA - Each76420-845c770339f-a861-436c-a8cf-808b214f7fba12025-08-11
76420-845-14EA - Each76420-84592f91c1b-dd0d-48ff-acb4-6dcc2d22f8b712025-08-11
76420-845-20EA - Each76420-84569edeb6a-6c68-468d-83fe-8c615531329a12025-08-11
76420-845-30EA - Each76420-845a2fb4909-e06b-495c-9c1e-57846246617412025-08-11
76420-845-60EA - Each76420-84556cb9000-d44c-4eb2-b400-4e6cea29779412025-08-11
76420-845-90EA - Each76420-8457da9f567-59e2-47aa-bede-d57e67d45fc512025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-845CELECOXIB 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
76420-845-01764200845011 CAPSULE in 1 BOTTLE (76420-845-01) 1 capsule2024-08-17NoNoHistorical
76420-845-0576420084505500 CAPSULE in 1 BOTTLE (76420-845-05) 500 capsule2024-08-17NoNoHistorical
76420-845-07764200845077 CAPSULE in 1 BOTTLE (76420-845-07) 7 capsule2024-08-17NoNoHistorical
76420-845-147642008451414 CAPSULE in 1 BOTTLE (76420-845-14) 14 capsule2024-08-17NoNoHistorical
76420-845-207642008452020 CAPSULE in 1 BOTTLE (76420-845-20) 20 capsule2024-08-17NoNoHistorical
76420-845-307642008453030 CAPSULE in 1 BOTTLE (76420-845-30) 30 capsule2024-08-17NoNoHistorical
76420-845-607642008456060 CAPSULE in 1 BOTTLE (76420-845-60) 60 capsule2024-08-17NoNoHistorical
76420-845-907642008459090 CAPSULE in 1 BOTTLE (76420-845-90) 90 capsule2024-08-17NoNoHistorical