MedPath
FDA Product

ergotamine tartrate and caffeine

Product approved by U.S. Food and Drug Administration (US)

Basic Information

ergotamine tartrate and caffeine

24470-917

Regulatory Information

24470-917

ANDA040590

C73584

December 21, 2021

USA

Ergotamine Tartrate and Caffeine Tablets, USP 1 mg/100 mg

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

078304114

Active Ingredients

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYVINYL ALCOHOL

Code: 532B59J990

Class Code: IACT

FD&C YELLOW NO. 5

Code: I753WB2F1M

Class Code: IACT

ERGOTAMINE TARTRATE

Quantity: 1 mg in 1 1

Code: MRU5XH3B48

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

CAFFEINE

Quantity: 100 mg in 1 1

Code: 3G6A5W338E

Class Code: ACTIB

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

Active Moieties

CAFFEINE

Code: 3G6A5W338E

ERGOTAMINE

Code: PR834Q503T

© Copyright 2025. All Rights Reserved by MedPath