ergotamine tartrate and caffeine

Product NDC: 46672-198
11-digit product format: 466720198
Labeler code: 46672
Product ID: 46672-198_a7a68c7f-301a-642d-e053-2995a90ae8a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ergotamine tartrate and caffeine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mikart, LLC
Application: ANDA040590
Marketing category: ANDA
Marketing start: 2005-09-16
Marketing end: 0000-00-00
Substance: ERGOTAMINE TARTRATE; CAFFEINE
Active strength: 1 mg/1; mg/1
Pharmacologic classes: Ergotamine Derivative [EPC],Ergotamines [CS],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	CAFFEINE; ERGOTAMINE TARTRATE	100MG;1MG	TABLET / ORAL		RS	2005-09-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL	AA		2005-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL	AA		2005-09-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL	AA		2005-09-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL	AA		2005-09-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL	AA		2005-09-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL	AA		2005-09-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL	AA		2005-09-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL	AA		2005-09-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040590-001	ERGOTAMINE TARTRATE AND CAFFEINE	100MG;1MG	TABLET / ORAL		RS	2005-09-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040590-001	AA	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040590-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040590-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040590-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040590-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040590-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040590-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040590-001	AA	1	`ea99ee380514…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [MIKART, INC.]	2
ERGOTAMINE TARTRATE	ACTIVE INGREDIENT	MRU5XH3B48	ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [MIKART, INC.]	2
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [MIKART, INC.]	2
ERGOTAMINE	ACTIVE MOIETY	PR834Q503T	ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [MIKART, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [MIKART, INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [MIKART, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [MIKART, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [MIKART, INC.]	2
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [MIKART, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [MIKART, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [MIKART, INC.]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [MIKART, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [MIKART, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [MIKART, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [MIKART, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [MIKART, INC.]	2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cafergot	ERGOTAMINE TARTRATE AND CAFFEINE	Trifluent Pharma, LLC	4db7eece-2eef-bc1b-e063-6394a90a98cb	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040590 application number: ANDA040590
ergotamine tartrate and caffeine	ERGOTAMINE TARTRATE AND CAFFEINE	Cintex Services, LLC	41f88ae7-c124-5b9c-e054-00144ff88e88	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040590 application number: ANDA040590

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MRU5XH3B48	ERGOTAMINE TARTRATE	379-79-3	ERGOTAMINE TARTRATE
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46672-198-01	46672019801	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46672-198-01)	2005-09-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ergotamine Tartrate and Caffeine Tablets, USP 1 mg/100 mg	Mikart, LLC	2020-06-09	HUMAN PRESCRIPTION DRUG LABEL	6