Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methyldopa
Product Details
NDC Product Code
54868-1328Application Number
ANDA070343Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 22, 2011MethyldopaActive
Code: 56LH93261YClass: ACTIBQuantity: 500 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4BClass: IACT
METHYLCELLULOSE (400 CPS)Inactive
Code: O0GN6F9B2YClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
Methyldopa
Product Details
NDC Product Code
54868-0050Application Number
ANDA070098Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 22, 2011CALCIUM SULFATEInactive
Code: WAT0DDB505Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4BClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
MethyldopaActive
Code: 56LH93261YClass: ACTIBQuantity: 250 mg in 1 1
METHYLCELLULOSE (400 CPS)Inactive
Code: O0GN6F9B2YClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT