Home NDC 81279-104-03 Ergomar
Product NDC 81279-104
Requested package NDC 81279-104-03
11-digit product format 812790104
Labeler code 81279
Product ID 81279-104_2ef9fa55-cdc3-dc0a-e063-6394a90a0e5f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ergotamine Tartrate
Dosage form TABLET
Route ORAL
Labeler Pangea Pharmaceuticals LLC
Application ANDA087693
Marketing category ANDA
Marketing start 2025-02-03
Substance ERGOTAMINE TARTRATE
Active strength 2 mg/1
Pharmacologic classes Ergotamine Derivative [EPC], Ergotamines [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 1 .
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 A087693-001 ERGOMAR ERGOTAMINE TARTRATE 2MG TABLET / SUBLINGUAL RS 1983-02-24
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A087693-001 ERGOMAR 2MG TABLET / SUBLINGUAL RS 1983-02-24 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Ergomar
Brand name suffix Sublingual
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ERGOTAMINE TARTRATE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MRU5XH3B48 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1293862 Internal RxNorm lookup 1293864 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 81279-104-03 Ergomar Sublingual 1 in 1 CARTON TABLET 1 2 81279-104-03 Ergomar Sublingual 3 in 1 BLISTER PACK TABLET 3 2 81279-104-20 Ergomar Sublingual 2 in 1 CARTON TABLET 2 2 81279-104-20 Ergomar Sublingual 10 in 1 BLISTER PACK TABLET 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81279-104 ERGOMAR SUBLINGUAL (ERGOTAMINE TARTRATE) TABLET [PANGEA PHARMACEUTICALS LLC] 2 Current NDC, 4 package rows 20250227_a9582fdb-7ddd-4f69-aa7a-66247cdb8c92.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81279-104-03 81279010403 1 BLISTER PACK in 1 CARTON (81279-104-03) / 3 TABLET in 1 BLISTER PACK 1 blister pack 2025-02-03 No No Current