Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Chartwell Pharmaceuticals Congers, LLC
Chartwell RX, LLC
118673447
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
62135-321Application Number
NDA018934Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
January 4, 2023LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4BClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MethyldopaActive
Code: 56LH93261YClass: ACTIMQuantity: 250 mg in 1 1
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
Methyldopa
Product Details
NDC Product Code
62135-322Application Number
NDA018934Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
January 4, 2023LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MethyldopaActive
Code: 56LH93261YClass: ACTIMQuantity: 500 mg in 1 1
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4BClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT