Meprobamate
Meprobamate Tablets USP Rx only
Approved
Approval ID
3b255bcd-0218-44f8-830b-971f5ec45276
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2021
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
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 Code62332-019
Application NumberANDA090122
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meprobamate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2021
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MEPROBAMATEActive
Quantity: 200 mg in 1 1
Code: 9I7LNY769Q
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Meprobamate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-020
Application NumberANDA090122
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meprobamate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2021
FDA Product Classification
INGREDIENTS (6)
MEPROBAMATEActive
Quantity: 400 mg in 1 1
Code: 9I7LNY769Q
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT