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Methylergonovine Maleate

Methylergonovine Maleate Tablets, USP Rx Only

Approved
Approval ID

b49b1e4c-de20-446d-b80a-75c7f0d41ddf

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 26, 2023

Manufacturers
FDA

Granules Pharmaceuticals Inc.

DUNS: 079825711

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

NDC Product Code70010-786
Application NumberANDA210424
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 26, 2023
Generic NameMethylergonovine Maleate

INGREDIENTS (11)

STARCH, CORNInactive
Code: O8232NY3SJ
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
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
METHYLERGONOVINE MALEATEActive
Quantity: 0.2 mg in 1 1
Code: IR84JPZ1RK
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT

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Methylergonovine Maleate - FDA Drug Approval Details