Home NDC 0713-0166 MIGERGOT
Product NDC 0713-0166
11-digit product format 007130166
Labeler code 0713
Product ID 0713-0166_ee9c58f6-c353-2cf3-e053-2a95a90a3f5e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ergotamine Tartrate and Caffeine
Dosage form SUPPOSITORY
Route RECTAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA086557
Marketing category ANDA
Marketing start 1983-10-30
Substance CAFFEINE; ERGOTAMINE TARTRATE
Active strength 100; 2 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A086557-001 MIGERGOT CAFFEINE; ERGOTAMINE TARTRATE 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04
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 · 42 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 2026-08-18 06:07:40 2026-07 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RS 1983-10-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RS 1983-10-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RS 1983-10-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RS 1983-10-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RS 1983-10-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RS 1983-10-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RS 1983-10-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RS 1983-10-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RS 1983-10-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RS 1983-10-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RS 1983-10-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RS 1983-10-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RS 1983-10-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A086557-001 MIGERGOT 100MG;2MG SUPPOSITORY / RECTAL RLD, RS 1983-10-04 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base MIGERGOT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ERGOTAMINE TARTRATE 2 mg/1 CAFFEINE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MRU5XH3B48 Internal UNII lookup 3G6A5W338E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1293508 Internal RxNorm lookup 1293639 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0713-0166-12 MIGERGOT 12 in 1 BOX SUPPOSITORY 12 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0166 MIGERGOT (ERGOTAMINE TARTRATE AND CAFFEINE) SUPPOSITORY [COSETTE PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20221130_3a31ad0c-7bdd-544b-f5df-a99d04cf541c.zip
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MIGERGOT ERGOTAMINE TARTRATE AND CAFFEINE Cosette Pharmaceuticals, Inc. 3a31ad0c-7bdd-544b-f5df-a99d04cf541c 2022-11-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 086557 application number: ANDA086557 ndc (product): 0713-0166
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0713-0166-12 00713016612 12 SUPPOSITORY in 1 BOX (0713-0166-12) 12 suppository 1983-10-30 0000-00-00 No No Current