FDA.reportPublic FDA data

Celecoxib

Product NDC
50228-159
11-digit product format
502280159
Labeler code
50228
Product ID
50228-159_8143c6b3-7c13-4abe-af2a-23fbe3e6d48a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
ScieGen Pharmaceuticals, 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Celecoxib
Listing expiration
2027-12-31

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
50228-159-05Celecoxib500 in 1 BOTTLECAPSULE5008
50228-159-30Celecoxib30 in 1 BOTTLECAPSULE308
50228-159-60Celecoxib60 in 1 BOTTLECAPSULE608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-159CELECOXIB CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 3 package rows20250309_8709cbe7-3de1-4908-a0a9-53002bcee15b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN8709cbe7-3de1-4908-a0a9-53002bcee15b8
205323celecoxib 200 MG Oral CapsulePSN8709cbe7-3de1-4908-a0a9-53002bcee15b8
349514celecoxib 400 MG Oral CapsulePSN8709cbe7-3de1-4908-a0a9-53002bcee15b8
686379celecoxib 50 MG Oral CapsulePSN8709cbe7-3de1-4908-a0a9-53002bcee15b8
205322celecoxib 100 MG Oral CapsuleSCD8709cbe7-3de1-4908-a0a9-53002bcee15b8
205323celecoxib 200 MG Oral CapsuleSCD8709cbe7-3de1-4908-a0a9-53002bcee15b8
349514celecoxib 400 MG Oral CapsuleSCD8709cbe7-3de1-4908-a0a9-53002bcee15b8
686379celecoxib 50 MG Oral CapsuleSCD8709cbe7-3de1-4908-a0a9-53002bcee15b8
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
349514celecoxib 400 MG Oral CapsulePSN56127f57-7810-4f5d-a11d-e08fb2ed138b1
349514celecoxib 400 MG Oral CapsuleSCD56127f57-7810-4f5d-a11d-e08fb2ed138b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-159-0550228015905500 CAPSULE in 1 BOTTLE (50228-159-05) 500 capsule2020-12-030000-00-00NoNoCurrent
50228-159-305022801593030 CAPSULE in 1 BOTTLE (50228-159-30) 30 capsule2020-12-030000-00-00NoNoCurrent
50228-159-605022801596060 CAPSULE in 1 BOTTLE (50228-159-60) 60 capsule2020-12-030000-00-00NoNoCurrent