FDA.reportPublic FDA data

ergotamine tartrate and caffeine

Product NDC
24470-917
11-digit product format
244700917
Labeler code
24470
Product ID
24470-917_31576cda-7134-cc0b-e063-6294a90acef8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ergotamine tartrate and caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cintex Services, LLC
Application
ANDA040590
Marketing category
ANDA
Marketing start
2016-11-23
Substance
CAFFEINE; ERGOTAMINE TARTRATE
Active strength
100; 1 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ergotamine tartrate and caffeine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAFFEINE100 mg/1
ERGOTAMINE TARTRATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3G6A5W338E, MRU5XH3B48
Rxcui1293504

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
32fd258b-9140-42bc-be18-18756be615a0Product name120170614
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24470-917-10ergotamine tartrate and caffeine100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1005
24470-917-40ergotamine tartrate and caffeine40 in 1 BOTTLE, PLASTICTABLET, FILM COATED405

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24470-917-10EA - Each24470-917dce6a348-76a9-4ab8-8213-3e2dadc0ce2812017-03-06
24470-917-40EA - Each24470-917af69fb2b-1120-4f5b-b0d3-4fbe36089ea512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24470-917ERGOTAMINE TARTRATE AND CAFFEINE TABLET, FILM COATED [CINTEX SERVICES, LLC]5Current NDC, Legacy NDC, 2 package rows20250330_41f88ae7-c124-5b9c-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293504ergotamine tartrate 1 MG / caffeine 100 MG Oral TabletPSN41f88ae7-c124-5b9c-e054-00144ff88e885
1293504caffeine 100 MG / ergotamine tartrate 1 MG Oral TabletSCD41f88ae7-c124-5b9c-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24470-917-1024470091710100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24470-917-10) 2016-11-230000-00-00NoNoCurrent
24470-917-402447009174040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24470-917-40) 2025-03-27NoNoHistorical