FDA.reportPublic FDA data

Celecoxib

Product NDC
50228-158
11-digit product format
502280158
Labeler code
50228
Product ID
50228-158_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
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
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
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
50228-158-01Celecoxib100 in 1 BOTTLECAPSULE1008
50228-158-05Celecoxib500 in 1 BOTTLECAPSULE5008
50228-158-10Celecoxib1000 in 1 BOTTLECAPSULE10008
50228-158-30Celecoxib30 in 1 BOTTLECAPSULE308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-158-01EA - Each50228-1587ddd5173-05cf-48bc-b471-21e7f78e040612021-06-02
50228-158-05EA - Each50228-1585d761571-4ea9-4a89-8d71-d404b03a87a112021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-158CELECOXIB CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 4 package rows20250309_8709cbe7-3de1-4908-a0a9-53002bcee15b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN0d89c39e-4858-4255-9127-1366e005203c103
205323celecoxib 200 MG Oral CapsuleSCD0d89c39e-4858-4255-9127-1366e005203c103
205323celecoxib 200 MG Oral CapsulePSN8a1e9a52-4627-4098-8a11-25e92ad96023102
205323celecoxib 200 MG Oral CapsuleSCD8a1e9a52-4627-4098-8a11-25e92ad96023102
205323celecoxib 200 MG Oral CapsulePSN06076494-62ad-4f58-b8bb-7038fcfe3b1212
205323celecoxib 200 MG Oral CapsuleSCD06076494-62ad-4f58-b8bb-7038fcfe3b1212
205322celecoxib 100 MG Oral CapsulePSN8709cbe7-3de1-4908-a0a9-53002bcee15b8
205323celecoxib 200 MG Oral CapsulePSN8709cbe7-3de1-4908-a0a9-53002bcee15b8
205323celecoxib 200 MG Oral CapsulePSNb3acbfd9-a1c2-4aa6-b5f0-013cfad6cca88
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 CapsuleSCDb3acbfd9-a1c2-4aa6-b5f0-013cfad6cca88
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
205323celecoxib 200 MG Oral CapsulePSN528a6f12-9878-4005-8fc2-5997adbb287f5
205323celecoxib 200 MG Oral CapsulePSNf2a5ffbd-49c4-4a97-867b-2b14a36750205
205323celecoxib 200 MG Oral CapsuleSCDf2a5ffbd-49c4-4a97-867b-2b14a36750205
205323celecoxib 200 MG Oral CapsuleSCD528a6f12-9878-4005-8fc2-5997adbb287f5
205323celecoxib 200 MG Oral CapsulePSNe1ab644d-b668-3cf3-e053-2995a90addb04
205323celecoxib 200 MG Oral CapsuleSCDe1ab644d-b668-3cf3-e053-2995a90addb04
205322celecoxib 100 MG Oral CapsulePSN5d0dcac1-237c-47aa-bcfb-50fa20b5b8383
205323celecoxib 200 MG Oral CapsulePSN5d0dcac1-237c-47aa-bcfb-50fa20b5b8383
205323celecoxib 200 MG Oral CapsulePSNfcf49d7f-8319-4051-b7ac-fe063268b39b3
205323celecoxib 200 MG Oral CapsulePSNdfdc74e8-1e4e-53e1-e053-2995a90abc523
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 CapsuleSCDfcf49d7f-8319-4051-b7ac-fe063268b39b3
205323celecoxib 200 MG Oral CapsuleSCDdfdc74e8-1e4e-53e1-e053-2995a90abc523
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
205323celecoxib 200 MG Oral CapsulePSNb9a7f32c-8136-4f29-be6b-4d5e904ca0f12
205323celecoxib 200 MG Oral CapsulePSNe0f3aacf-df5d-dad7-e053-2995a90ac5eb2
205323celecoxib 200 MG Oral CapsulePSNf3d26067-1270-7852-e053-2995a90a434b2
205323celecoxib 200 MG Oral CapsuleSCDb9a7f32c-8136-4f29-be6b-4d5e904ca0f12
205323celecoxib 200 MG Oral CapsuleSCDe0f3aacf-df5d-dad7-e053-2995a90ac5eb2
205323celecoxib 200 MG Oral CapsuleSCDf3d26067-1270-7852-e053-2995a90a434b2
205323celecoxib 200 MG Oral CapsulePSN14962aef-7609-b29a-e063-6394a90a53991
205323celecoxib 200 MG Oral CapsulePSN15d6ef4f-568d-9d3e-e063-6294a90ab04c1
205323celecoxib 200 MG Oral CapsulePSN3a7b127e-c919-418f-e063-6394a90a06d01
205323celecoxib 200 MG Oral CapsuleSCD14962aef-7609-b29a-e063-6394a90a53991
205323celecoxib 200 MG Oral CapsuleSCD15d6ef4f-568d-9d3e-e063-6294a90ab04c1
205323celecoxib 200 MG Oral CapsuleSCD3a7b127e-c919-418f-e063-6394a90a06d01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-158-0150228015801100 CAPSULE in 1 BOTTLE (50228-158-01) 100 capsule2020-12-030000-00-00NoNoCurrent
50228-158-0550228015805500 CAPSULE in 1 BOTTLE (50228-158-05) 500 capsule2020-12-030000-00-00NoNoCurrent
50228-158-10502280158101000 CAPSULE in 1 BOTTLE (50228-158-10) 1000 capsule2020-12-030000-00-00NoNoCurrent
50228-158-305022801583030 CAPSULE in 1 BOTTLE (50228-158-30) 30 capsule2020-12-030000-00-00NoNoCurrent