Methylergonovine Maleate
Methylergonovine Maleate Tablets USP A211455
Approved
Approval ID
2fbdc9c4-b9d4-4796-adda-6144bdea0990
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2020
Manufacturers
FDA
ATLANTIC BIOLOGICALS CORP.
DUNS: 047437707
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 Code17856-3655
Application NumberANDA211455
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylergonovine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2020
FDA Product Classification
INGREDIENTS (11)
METHYLERGONOVINE MALEATEActive
Quantity: 0.2 mg in 1 1
Code: IR84JPZ1RK
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT