FDA.reportPublic FDA data

ERGOTAMINE

Product NDC
0143-2120
11-digit product format
001432120
Labeler code
0143
Product ID
0143-2120_2dd70d46-765d-434d-92e6-4f8974dc31af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ergotamine tartrate and caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
West-Ward Pharmaceutical Corp
Application
ANDA040510
Marketing category
ANDA
Marketing start
2004-09-17
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0143-2120-012020-01-31C16284748780-19d75b9d0-67fc-f424-e053-dadaa90a57ceErgotamine Tartrate and Caffeine
0143-2120-052020-01-31C16284748780-19d75b9d0-67fc-f424-e053-dadaa90a57ceErgotamine Tartrate and Caffeine
0143-2120-302020-01-31C16284748780-19d75b9d0-67fc-f424-e053-dadaa90a57ceErgotamine Tartrate and Caffeine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-2120-01ERGOTAMINE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002
0143-2120-05ERGOTAMINE500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5002
0143-2120-30ERGOTAMINE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAFFEINEACTIVE INGREDIENT3G6A5W338EERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
ERGOTAMINE TARTRATEACTIVE INGREDIENTMRU5XH3B48ERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
CAFFEINEACTIVE MOIETY3G6A5W338EERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
ERGOTAMINEACTIVE MOIETYPR834Q503TERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
SUCROSEINACTIVE INGREDIENTC151H8M554ERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-2120ERGOTAMINE (ERGOTAMINE TARTRATE AND CAFFEINE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2Legacy NDC, 3 package rows20130410_19479eeb-f507-48a8-bca3-c9cc0a0f6021.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293504ergotamine tartrate 1 MG / caffeine 100 MG Oral TabletPSN19479eeb-f507-48a8-bca3-c9cc0a0f60212
1293504caffeine 100 MG / ergotamine tartrate 1 MG Oral TabletSCD19479eeb-f507-48a8-bca3-c9cc0a0f60212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0143-2120-0100143212001100 in 1 BOTTLE, PLASTICHistorical
0143-2120-0500143212005500 in 1 BOTTLE, PLASTICHistorical
0143-2120-300014321203030 in 1 BOTTLE, PLASTICHistorical