Methyldopa
METHYLDOPA TABLETS USPRx only
Approved
Approval ID
c8bea68b-3932-4538-b568-a296a8817291
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methyldopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1328
Application NumberANDA070343
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methyldopa
Product Specifications
Route of AdministrationORAL
Effective DateMarch 22, 2011
FDA Product Classification
INGREDIENTS (12)
METHYLDOPAActive
Quantity: 500 mg in 1 1
Code: 56LH93261Y
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
METHYLCELLULOSE (400 CPS)Inactive
Code: O0GN6F9B2Y
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Methyldopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0050
Application NumberANDA070098
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methyldopa
Product Specifications
Route of AdministrationORAL
Effective DateMarch 22, 2011
FDA Product Classification
INGREDIENTS (14)
CALCIUM SULFATEInactive
Code: WAT0DDB505
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
METHYLDOPAActive
Quantity: 250 mg in 1 1
Code: 56LH93261Y
Classification: ACTIB
METHYLCELLULOSE (400 CPS)Inactive
Code: O0GN6F9B2Y
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT