MIGERGOT
ERGOTAMINE TARTRATE and CAFFEINE SUPPOSITORIES USP (For Rectal Administration) Rx only
Approved
Approval ID
3a31ad0c-7bdd-544b-f5df-a99d04cf541c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2022
Manufacturers
FDA
Cosette Pharmaceuticals, Inc.
DUNS: 116918230
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ergotamine Tartrate and Caffeine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0713-0166
Application NumberANDA086557
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ergotamine Tartrate and Caffeine
Product Specifications
Route of AdministrationRECTAL
Effective DateNovember 29, 2022
FDA Product Classification
INGREDIENTS (4)
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
HARD FATInactive
Code: 8334LX7S21
Classification: IACT
ERGOTAMINE TARTRATEActive
Quantity: 2 mg in 1 1
Code: MRU5XH3B48
Classification: ACTIB
CAFFEINEActive
Quantity: 100 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB