Cafergot

Product NDC
73352-917
11-digit product format
733520917
Labeler code
73352
Product ID
73352-917_4db7f801-0dea-0ec8-e063-6294a90a2636
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ergotamine tartrate and caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Trifluent Pharma, LLC
Application
ANDA040590
Marketing category
ANDA
Marketing start
2026-03-23
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
2027-12-31
Current FDA listing
Yes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040590-001ERGOTAMINE TARTRATE AND CAFFEINECAFFEINE; ERGOTAMINE TARTRATE100MG;1MGTABLET / ORALRS2005-09-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALAA2005-09-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALAA2005-09-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALAA2005-09-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALAA2005-09-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALAA2005-09-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALAA2005-09-163f01610625f2…
2019-09-15 20:21 UTC2019-09A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALAA2005-09-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALAA2005-09-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040590-001ERGOTAMINE TARTRATE AND CAFFEINE100MG;1MGTABLET / ORALRS2005-09-16cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A040590-001AA174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040590-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040590-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040590-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040590-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040590-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040590-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040590-001AA1ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Cafergot
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERGOTAMINE TARTRATE100 mg/1
CAFFEINE1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MRU5XH3B48Internal UNII lookup
3G6A5W338EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1293504Internal RxNorm lookup
1293506Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4db7eece-2eef-bc1b-e063-6394a90a98cbAvailable on FDA.report

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
73352-917-40Cafergot40 in 1 BOTTLE, PLASTICTABLET, FILM COATED401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-917-40EA - Each73352-9170ffd928d-9584-4e70-b8c1-cec2f5fa790112026-04-20

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CafergotERGOTAMINE TARTRATE AND CAFFEINETrifluent Pharma, LLC4db7eece-2eef-bc1b-e063-6394a90a98cb2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040590
application number: ANDA040590
ndc (product): 73352-917
ergotamine tartrate and caffeineERGOTAMINE TARTRATE AND CAFFEINECintex Services, LLC41f88ae7-c124-5b9c-e054-00144ff88e882025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040590
application number: ANDA040590

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293506Cafergot 1 MG / 100 MG Oral TabletPSN4db7eece-2eef-bc1b-e063-6394a90a98cb1
1293504ergotamine tartrate 1 MG / caffeine 100 MG Oral TabletPSN4db7eece-2eef-bc1b-e063-6394a90a98cb1
1293506caffeine 100 MG / ergotamine tartrate 1 MG Oral Tablet [Cafergot]SBD4db7eece-2eef-bc1b-e063-6394a90a98cb1
1293504caffeine 100 MG / ergotamine tartrate 1 MG Oral TabletSCD4db7eece-2eef-bc1b-e063-6394a90a98cb1
1293506Cafergot (caffeine 100 MG / ergotamine tartrate 1 MG) Oral TabletSY4db7eece-2eef-bc1b-e063-6394a90a98cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73352-917-407335209174040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73352-917-40) 2026-03-23NoNoCurrent