Home NDC 69238-1539 Frovatriptan
Product NDC 69238-1539
11-digit product format 692381539
Labeler code 69238
Product ID 69238-1539_b44b534c-17a5-4a71-a3e5-7d98adb4cdd1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Frovatriptan succinate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA211292
Marketing category ANDA
Marketing start 2018-11-13
Substance FROVATRIPTAN SUCCINATE
Active strength 2.5 mg/1
Pharmacologic classes Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211292-001 FROVATRIPTAN SUCCINATE FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211292-001 AB
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 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL 2018-11-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211292-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2018-11-06 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Frovatriptan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FROVATRIPTAN SUCCINATE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D28J6W18HY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349462 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 69238-1539-9 Frovatriptan 9 in 1 BLISTER PACK TABLET, FILM COATED 9 11 69238-1539-9 Frovatriptan 1 in 1 CARTON TABLET, FILM COATED 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1539 FROVATRIPTAN (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] 10 Current NDC, Legacy NDC, 2 package rows 20240718_94b996dc-ddc4-41ce-9a9f-3d91cb187473.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 Marketing end Sample Exclude flag Status 69238-1539-9 69238153909 1 BLISTER PACK in 1 CARTON (69238-1539-9) / 9 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2018-11-13 0000-00-00 No No Current