Ergomar
Ergomar Sublingual Tablets, 2 mg
Approved
Approval ID
dac9637f-3326-4f25-b7b9-f9f54b738232
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2022
Manufacturers
FDA
TerSera Therapeutics, LLC
DUNS: 080226115
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ergotamine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70720-120
Application NumberANDA087693
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ergotamine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2016
FDA Product Classification
INGREDIENTS (8)
Ergotamine TartrateActive
Quantity: 2 mg in 1 1
Code: MRU5XH3B48
Classification: ACTIB
CrospovidoneInactive
Code: 2S7830E561
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Saccharin SodiumInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C Blue NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
D&C Yellow NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT