FDA.reportPublic FDA data

Diacomit

Product NDC
68418-7942
11-digit product format
684187942
Labeler code
68418
Product ID
68418-7942_7c968964-991e-4ec2-bc03-ef062b5bb0f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
stiripentol
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
BIOCODEX, INC.
Application
NDA207223
Marketing category
NDA
Marketing start
2018-08-21
Substance
STIRIPENTOL
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STIRIPENTOL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR02XOT8V8I
Rxcui2054973, 2054979, 2054981, 2054983, 2055011, 2055014, 2055015, 2055016

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b726dffa-7bfc-4c08-889d-a3080b224d14Product name120181127

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68418-7942-62024-06-04C16284748780-11030e365-0d7f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIACOMIT safely and effectively. See full prescribing information for DIACOMIT. DIACOMIT (stiripentol) capsules, for oral use DIACOMIT (stiripentol) for oral suspension Initial U.S. Approval: 2018
68418-7942-62024-01-30C16284748780-11030e365-0d7f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIACOMIT safely and effectively. See full prescribing information for DIACOMIT. DIACOMIT (stiripentol) capsules, for oral use DIACOMIT (stiripentol) for oral suspension Initial U.S. Approval: 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68418-7942-6Diacomit60 in 1 CARTONPOWDER, FOR SUSPENSION608
68418-7942-6Diacomit1 in 1 PACKETPOWDER, FOR SUSPENSION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68418-7942-6EA - Each68418-794299bffc77-1027-4ba6-a0fd-d446312d1c0212019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68418-7942DIACOMIT (STIRIPENTOL) CAPSULE DIACOMIT (STIRIPENTOL) POWDER, FOR SUSPENSION [BIOCODEX, INC.]7Current NDC, Legacy NDC, 2 package rows20240608_58304ba8-9779-4658-811e-94ffe08c3f16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2054979DIACOMIT 250 MG Oral CapsulePSN58304ba8-9779-4658-811e-94ffe08c3f168
2055016DIACOMIT 250 MG Powder for Oral SuspensionPSN58304ba8-9779-4658-811e-94ffe08c3f168
2054983DIACOMIT 500 MG Oral CapsulePSN58304ba8-9779-4658-811e-94ffe08c3f168
2055014DIACOMIT 500 MG Powder for Oral SuspensionPSN58304ba8-9779-4658-811e-94ffe08c3f168
2054973stiripentol 250 MG Oral CapsulePSN58304ba8-9779-4658-811e-94ffe08c3f168
2055015stiripentol 250 MG Powder for Oral SuspensionPSN58304ba8-9779-4658-811e-94ffe08c3f168
2054981stiripentol 500 MG Oral CapsulePSN58304ba8-9779-4658-811e-94ffe08c3f168
2055011stiripentol 500 MG Powder for Oral SuspensionPSN58304ba8-9779-4658-811e-94ffe08c3f168
2054979stiripentol 250 MG Oral Capsule [Diacomit]SBD58304ba8-9779-4658-811e-94ffe08c3f168
2055016stiripentol 250 MG Powder for Oral Suspension [Diacomit]SBD58304ba8-9779-4658-811e-94ffe08c3f168
2054983stiripentol 500 MG Oral Capsule [Diacomit]SBD58304ba8-9779-4658-811e-94ffe08c3f168
2055014stiripentol 500 MG Powder for Oral Suspension [Diacomit]SBD58304ba8-9779-4658-811e-94ffe08c3f168
2054973stiripentol 250 MG Oral CapsuleSCD58304ba8-9779-4658-811e-94ffe08c3f168
2055015stiripentol 250 MG Powder for Oral SuspensionSCD58304ba8-9779-4658-811e-94ffe08c3f168
2054981stiripentol 500 MG Oral CapsuleSCD58304ba8-9779-4658-811e-94ffe08c3f168
2055011stiripentol 500 MG Powder for Oral SuspensionSCD58304ba8-9779-4658-811e-94ffe08c3f168
2054979Diacomit 250 MG Oral CapsuleSY58304ba8-9779-4658-811e-94ffe08c3f168
2055016Diacomit 250 MG Powder for Oral SuspensionSY58304ba8-9779-4658-811e-94ffe08c3f168
2054983Diacomit 500 MG Oral CapsuleSY58304ba8-9779-4658-811e-94ffe08c3f168
2055014Diacomit 500 MG Powder for Oral SuspensionSY58304ba8-9779-4658-811e-94ffe08c3f168

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68418-7942-66841879420660 PACKET in 1 CARTON (68418-7942-6) / 1 POWDER, FOR SUSPENSION in 1 PACKET60 packet2018-08-210000-00-00NoNoCurrent