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SUBVENITE

These highlights do not include all the information needed to use SUBVENITE safely and effectively. See full prescribing information for SUBVENITE. SUBVENITE (lamotrigine) tablets USP, for oral use Initial U.S. Approval: 1994

Approved
Approval ID

7ad18b68-ba16-4810-9c3e-27fa970454e8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 14, 2021

Manufacturers
FDA

OWP Pharmaceuticals, Inc.

DUNS: 079392532

Products 7

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

LAMOTRIGINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69102-312
Application NumberANDA078947
Product Classification
M
Marketing Category
C73584
G
Generic Name
LAMOTRIGINE
Product Specifications
Effective DateMay 14, 2021
FDA Product Classification

LAMOTRIGINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69102-150
Application NumberANDA078947
Product Classification
M
Marketing Category
C73584
G
Generic Name
LAMOTRIGINE
Product Specifications
Route of AdministrationORAL
Effective DateMay 14, 2021
FDA Product Classification

INGREDIENTS (1)

LAMOTRIGINEActive
Quantity: 150 mg in 1 1
Code: U3H27498KS
Classification: ACTIB

LAMOTRIGINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69102-320
Application NumberANDA078947
Product Classification
M
Marketing Category
C73584
G
Generic Name
LAMOTRIGINE
Product Specifications
Route of AdministrationORAL
Effective DateMay 14, 2021
FDA Product Classification

INGREDIENTS (1)

LAMOTRIGINEActive
Quantity: 200 mg in 1 1
Code: U3H27498KS
Classification: ACTIB

LAMOTRIGINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69102-319
Application NumberANDA078947
Product Classification
M
Marketing Category
C73584
G
Generic Name
LAMOTRIGINE
Product Specifications
Route of AdministrationORAL
Effective DateMay 14, 2021
FDA Product Classification

INGREDIENTS (6)

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LAMOTRIGINEActive
Quantity: 100 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT

LAMOTRIGINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69102-301
Application NumberANDA078947
Product Classification
M
Marketing Category
C73584
G
Generic Name
LAMOTRIGINE
Product Specifications
Route of AdministrationORAL
Effective DateMay 14, 2021
FDA Product Classification

INGREDIENTS (6)

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LAMOTRIGINEActive
Quantity: 25 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT

LAMOTRIGINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69102-300
Application NumberANDA078947
Product Classification
M
Marketing Category
C73584
G
Generic Name
LAMOTRIGINE
Product Specifications
Effective DateMay 14, 2021
FDA Product Classification

LAMOTRIGINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69102-306
Application NumberANDA078947
Product Classification
M
Marketing Category
C73584
G
Generic Name
LAMOTRIGINE
Product Specifications
Effective DateMay 14, 2021
FDA Product Classification

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SUBVENITE - FDA Drug Approval Details