FDA.reportPublic FDA data

Celecoxib

Product NDC
76420-844
11-digit product format
764200844
Labeler code
76420
Product ID
76420-844_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
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
76420-844-00Celecoxib1000 in 1 BOTTLECAPSULE10003
76420-844-01Celecoxib1 in 1 BOTTLECAPSULE13
76420-844-05Celecoxib500 in 1 BOTTLECAPSULE5003
76420-844-07Celecoxib7 in 1 BOTTLECAPSULE73
76420-844-10Celecoxib100 in 1 BOTTLECAPSULE1003
76420-844-12Celecoxib120 in 1 BOTTLECAPSULE1203
76420-844-14Celecoxib14 in 1 BOTTLECAPSULE143
76420-844-20Celecoxib20 in 1 BOTTLECAPSULE203
76420-844-30Celecoxib30 in 1 BOTTLECAPSULE303
76420-844-60Celecoxib60 in 1 BOTTLECAPSULE603
76420-844-90Celecoxib90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-844-00EA - Each76420-844ee48ba35-f1db-4c83-8e44-91be1688756c12025-08-11
76420-844-01EA - Each76420-844a461ed58-6d93-4349-a31f-080c63c3f6c112025-08-11
76420-844-05EA - Each76420-84451cb0ea3-3057-4a66-b0b1-1794e2a01d5012025-08-11
76420-844-07EA - Each76420-8444c2e6e0f-7ae4-4b3a-a849-c66535b639f212025-08-11
76420-844-10EA - Each76420-844f0714f60-b3f8-4c2c-b0ba-6c0c7d61722312025-08-11
76420-844-12EA - Each76420-844a8fdf2f2-9bf3-4a07-a378-1a3de1f80d1712025-08-11
76420-844-14EA - Each76420-8443b1ea380-d741-4c44-890f-fea46fb84e1012025-08-11
76420-844-20EA - Each76420-84429c034bd-ca53-4354-88d4-cc9708ff66b012025-08-11
76420-844-30EA - Each76420-844a3b665cc-0ca3-44e5-97da-f2248bf2b3d712025-08-11
76420-844-60EA - Each76420-844b273c896-7ba4-4a30-b68d-639e2b3cab9212025-08-11
76420-844-90EA - Each76420-8444e2ca7ac-7bf1-4fbf-ae51-359dae62e87212025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-844CELECOXIB CAPSULE [ASCLEMED USA, INC.]3Current NDC, 11 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
76420-844-00764200844001000 CAPSULE in 1 BOTTLE (76420-844-00) 1000 capsule2024-08-17NoNoHistorical
76420-844-01764200844011 CAPSULE in 1 BOTTLE (76420-844-01) 1 capsule2024-08-17NoNoHistorical
76420-844-0576420084405500 CAPSULE in 1 BOTTLE (76420-844-05) 500 capsule2024-08-17NoNoHistorical
76420-844-07764200844077 CAPSULE in 1 BOTTLE (76420-844-07) 7 capsule2024-08-17NoNoHistorical
76420-844-1076420084410100 CAPSULE in 1 BOTTLE (76420-844-10) 100 capsule2024-08-17NoNoHistorical
76420-844-1276420084412120 CAPSULE in 1 BOTTLE (76420-844-12) 120 capsule2025-04-11NoNoHistorical
76420-844-147642008441414 CAPSULE in 1 BOTTLE (76420-844-14) 14 capsule2024-08-17NoNoHistorical
76420-844-207642008442020 CAPSULE in 1 BOTTLE (76420-844-20) 20 capsule2024-08-17NoNoHistorical
76420-844-307642008443030 CAPSULE in 1 BOTTLE (76420-844-30) 30 capsule2024-08-17NoNoHistorical
76420-844-607642008446060 CAPSULE in 1 BOTTLE (76420-844-60) 60 capsule2024-08-17NoNoHistorical
76420-844-907642008449090 CAPSULE in 1 BOTTLE (76420-844-90) 90 capsule2024-08-17NoNoHistorical