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Methyldopa

Methyldopa Tablets, USP Rx only

Approved
Approval ID

e503c0bf-c326-48fb-8967-0f476eaa8961

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 3, 2015

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

Products 1

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 Code68151-2791
Application NumberANDA070084
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methyldopa
Product Specifications
Route of AdministrationORAL
Effective DateDecember 3, 2015
FDA Product Classification

INGREDIENTS (9)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
METHYLDOPAActive
Quantity: 250 mg in 1 1
Code: 56LH93261Y
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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Methyldopa - FDA Drug Approval Details