ergotamine tartrate and caffeine
Ergotamine Tartrate and Caffeine Tablets, USP 1 mg/100 mg
Approved
Approval ID
41f88ae7-c124-5b9c-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2021
Manufacturers
FDA
Cintex Services, LLC
DUNS: 078304114
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 Code24470-917
Application NumberANDA040590
Product Classification
M
Marketing Category
C73584
G
Generic Name
ergotamine tartrate and caffeine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2021
FDA Product Classification
INGREDIENTS (14)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
ERGOTAMINE TARTRATEActive
Quantity: 1 mg in 1 1
Code: MRU5XH3B48
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CAFFEINEActive
Quantity: 100 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT