Methylergonovine Maleate
Methylergonovine Maleate Tablets, USP Rx Only
Approved
Approval ID
70106231-37f5-3e64-e053-2991aa0ab9af
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2023
Manufacturers
FDA
West-Ward Pharmaceuticals Corp
DUNS: 080189610
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methylergonovine Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0639
Application NumberANDA210424
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylergonovine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2023
FDA Product Classification
INGREDIENTS (11)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLERGONOVINE MALEATEActive
Quantity: 0.2 mg in 1 1
Code: IR84JPZ1RK
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
Drug Labeling Information
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 2/14/2017
DOSAGE & ADMINISTRATION
Orally
One tablet, 0.2 mg, 3 or 4 times daily in the puerperium for a maximum of 1
week.