FDA.reportPublic FDA data

Celecoxib

Product NDC
76420-843
11-digit product format
764200843
Labeler code
76420
Product ID
76420-843_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
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
76420-843-00Celecoxib1000 in 1 BOTTLECAPSULE10003
76420-843-01Celecoxib1 in 1 BOTTLECAPSULE13
76420-843-05Celecoxib500 in 1 BOTTLECAPSULE5003
76420-843-07Celecoxib7 in 1 BOTTLECAPSULE73
76420-843-10Celecoxib100 in 1 BOTTLECAPSULE1003
76420-843-14Celecoxib14 in 1 BOTTLECAPSULE143
76420-843-20Celecoxib20 in 1 BOTTLECAPSULE203
76420-843-30Celecoxib30 in 1 BOTTLECAPSULE303
76420-843-60Celecoxib60 in 1 BOTTLECAPSULE603
76420-843-90Celecoxib90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-843-00EA - Each76420-843b9fb039f-7249-4283-9b62-0ec97da5002812025-08-11
76420-843-01EA - Each76420-8435e60d7ed-4fa5-4395-be00-75f53592718d12025-08-11
76420-843-05EA - Each76420-843f66a98fe-e6b6-4de5-83fe-48266a567ce612025-08-11
76420-843-07EA - Each76420-843787e7f7b-a84a-47a2-b701-04921ca17b6312025-08-11
76420-843-10EA - Each76420-8434d2cb35f-b68d-4e4e-a2e3-c6e90b32579c12025-08-11
76420-843-14EA - Each76420-8436a80c42b-e668-451a-bafb-b585b37dbafe12025-08-11
76420-843-20EA - Each76420-84342322226-0f5c-4ec6-808a-14fc6cdc172c12025-08-11
76420-843-30EA - Each76420-8432f6f4171-9f73-44a6-9739-3d05057d9b5912025-08-11
76420-843-60EA - Each76420-843e2b9ca2f-7d90-4334-bb30-81b19cf850be12025-08-11
76420-843-90EA - Each76420-8434058b512-d869-4045-ad25-a8806aec45ab12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-843CELECOXIB CAPSULE [ASCLEMED USA, INC.]3Current NDC, 10 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
76420-843-00764200843001000 CAPSULE in 1 BOTTLE (76420-843-00) 1000 capsule2024-08-17NoNoHistorical
76420-843-01764200843011 CAPSULE in 1 BOTTLE (76420-843-01) 1 capsule2024-08-17NoNoHistorical
76420-843-0576420084305500 CAPSULE in 1 BOTTLE (76420-843-05) 500 capsule2024-08-17NoNoHistorical
76420-843-07764200843077 CAPSULE in 1 BOTTLE (76420-843-07) 7 capsule2024-08-17NoNoHistorical
76420-843-1076420084310100 CAPSULE in 1 BOTTLE (76420-843-10) 100 capsule2024-08-17NoNoHistorical
76420-843-147642008431414 CAPSULE in 1 BOTTLE (76420-843-14) 14 capsule2024-08-17NoNoHistorical
76420-843-207642008432020 CAPSULE in 1 BOTTLE (76420-843-20) 20 capsule2024-08-17NoNoHistorical
76420-843-307642008433030 CAPSULE in 1 BOTTLE (76420-843-30) 30 capsule2024-08-17NoNoHistorical
76420-843-607642008436060 CAPSULE in 1 BOTTLE (76420-843-60) 60 capsule2024-08-17NoNoHistorical
76420-843-907642008439090 CAPSULE in 1 BOTTLE (76420-843-90) 90 capsule2024-08-17NoNoHistorical