Meprobamate
Meprobamate Tablets USP CIV
Approved
Approval ID
4a9ad4f6-6826-4cb8-a097-2d2ea2c91d8b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2019
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Meprobamate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4147
Application NumberANDA200998
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meprobamate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2019
FDA Product Classification
INGREDIENTS (7)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
MeprobamateActive
Quantity: 200 mg in 1 1
Code: 9I7LNY769Q
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
sodium starch glycolate type a potatoInactive
Code: 5856J3G2A2
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
Meprobamate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4148
Application NumberANDA200998
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meprobamate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2019
FDA Product Classification
INGREDIENTS (7)
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
MeprobamateActive
Quantity: 400 mg in 1 1
Code: 9I7LNY769Q
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
sodium starch glycolate type a potatoInactive
Code: 5856J3G2A2
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT