Methyldopa
Methyldopa Tablets, USP
Approved
Approval ID
e1114a58-9ab5-486e-85ed-360365b06396
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-321
Application NumberNDA018934
Product Classification
M
Marketing Category
C73594
G
Generic Name
Methyldopa
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2023
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLDOPAActive
Quantity: 250 mg in 1 1
Code: 56LH93261Y
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Methyldopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-322
Application NumberNDA018934
Product Classification
M
Marketing Category
C73594
G
Generic Name
Methyldopa
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2023
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLDOPAActive
Quantity: 500 mg in 1 1
Code: 56LH93261Y
Classification: ACTIM
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT