Diacomit
These 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
Approved
Approval ID
58304ba8-9779-4658-811e-94ffe08c3f16
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 24, 2022
Manufacturers
FDA
BIOCODEX, INC.
DUNS: 792454464
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
stiripentol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68418-7941
Application NumberNDA207223
Product Classification
M
Marketing Category
C73594
G
Generic Name
stiripentol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 26, 2022
FDA Product Classification
INGREDIENTS (15)
StiripentolActive
Quantity: 250 mg in 1 1
Code: R02XOT8V8I
Classification: ACTIB
AspartameInactive
Code: Z0H242BBR1
Classification: IACT
Carboxymethylcellulose Sodium, Unspecified FormInactive
Code: K679OBS311
Classification: IACT
FD&C Red No. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
Dextrose, Unspecified FormInactive
Code: IY9XDZ35W2
Classification: IACT
Hydroxyethyl Cellulose (2000 Mpa.S At 1%)Inactive
Code: S38J6RZN16
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
AcaciaInactive
Code: 5C5403N26O
Classification: IACT
PovidoneInactive
Code: FZ989GH94E
Classification: IACT
Bergamot OilInactive
Code: 39W1PKE3JI
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
MaltodextrinInactive
Code: 7CVR7L4A2D
Classification: IACT
VanillinInactive
Code: CHI530446X
Classification: IACT
stiripentol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68418-7942
Application NumberNDA207223
Product Classification
M
Marketing Category
C73594
G
Generic Name
stiripentol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 26, 2022
FDA Product Classification
INGREDIENTS (15)
AspartameInactive
Code: Z0H242BBR1
Classification: IACT
Carboxymethylcellulose Sodium, Unspecified FormInactive
Code: K679OBS311
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
MaltodextrinInactive
Code: 7CVR7L4A2D
Classification: IACT
StiripentolActive
Quantity: 500 mg in 1 1
Code: R02XOT8V8I
Classification: ACTIB
FD&C Red No. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
Dextrose, Unspecified FormInactive
Code: IY9XDZ35W2
Classification: IACT
Hydroxyethyl Cellulose (2000 Mpa.S At 1%)Inactive
Code: S38J6RZN16
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
AcaciaInactive
Code: 5C5403N26O
Classification: IACT
Bergamot OilInactive
Code: 39W1PKE3JI
Classification: IACT
PovidoneInactive
Code: FZ989GH94E
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
VanillinInactive
Code: CHI530446X
Classification: IACT
stiripentol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68418-7939
Application NumberNDA206709
Product Classification
M
Marketing Category
C73594
G
Generic Name
stiripentol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 26, 2022
FDA Product Classification
INGREDIENTS (8)
FD&C Red No. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
StiripentolActive
Quantity: 250 mg in 1 1
Code: R02XOT8V8I
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PovidoneInactive
Code: FZ989GH94E
Classification: IACT
stiripentol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68418-7940
Application NumberNDA206709
Product Classification
M
Marketing Category
C73594
G
Generic Name
stiripentol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 26, 2022
FDA Product Classification
INGREDIENTS (6)
StiripentolActive
Quantity: 500 mg in 1 1
Code: R02XOT8V8I
Classification: ACTIB
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
PovidoneInactive
Code: FZ989GH94E
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT