MedPath

Mysoline

Anticonvulsant

Approved
Approval ID

af593171-dabb-4ea3-b44c-89ed457b2c46

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 6, 2020

Manufacturers
FDA

Bausch Health US, LLC

DUNS: 831922468

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Primidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66490-690
Application NumberNDA009170
Product Classification
M
Marketing Category
C73594
G
Generic Name
Primidone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2020
FDA Product Classification

INGREDIENTS (9)

PrimidoneActive
Quantity: 50 mg in 1 1
Code: 13AFD7670Q
Classification: ACTIB
lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
sodium starch glycolate type a potatoInactive
Code: 5856J3G2A2
Classification: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Primidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66490-691
Application NumberNDA009170
Product Classification
M
Marketing Category
C73594
G
Generic Name
Primidone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2020
FDA Product Classification

INGREDIENTS (10)

PrimidoneActive
Quantity: 250 mg in 1 1
Code: 13AFD7670Q
Classification: ACTIB
lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
sodium starch glycolate type a potatoInactive
Code: 5856J3G2A2
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

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Mysoline - FDA Drug Approval Details