ERGOTAMINE TARTRATE, CAFFEINE

Product NDC: 52187-555
11-digit product format: 521870555
Labeler code: 52187
Product ID: 52187-555_d7acf745-e17f-009d-e053-2a95a90ab32e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ERGOTAMINE TARTRATE, CAFFEINE
Dosage form: TABLET
Route: ORAL
Labeler: KMM Pharmaceuticals, LLC
Application: ANDA040590
Marketing category: ANDA
Marketing start: 2022-02-10
Marketing end: 0000-00-00
Substance: CAFFEINE; ERGOTAMINE TARTRATE
Active strength: 100 mg/1; mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Ergotamine Derivative [EPC], Ergotamines [CS], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52187-555-10	EA - Each	52187-555	57ed9c9d-f58d-4b2e-988c-08f6b652de0b	1	2022-03-09

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

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52187-555-10	52187055510	100 TABLET in 1 BOTTLE (52187-555-10)	100 tablet	2022-02-10	0000-00-00	No	No	Current