Home NDC 50742-299 FROVATRIPTAN
Product NDC 50742-299
11-digit product format 507420299
Labeler code 50742
Product ID 50742-299_447a8874-8a78-84a6-e063-6294a90aa3b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name frovatriptan succinate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ingenus Pharmaceuticals, LLC
Application ANDA213891
Marketing category ANDA
Marketing start 2022-07-22
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 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 A213891-001 FROVATRIPTAN SUCCINATE FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB RS 2022-04-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213891-001 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.
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 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 5d02ea3f76ae…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB 2022-04-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213891-001 FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL AB RS 2022-04-06 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base FROVATRIPTAN
Listing expiration 2026-12-31 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 50742-299-09 FROVATRIPTAN 1 in 1 CARTON TABLET, FILM COATED 1 6 50742-299-09 FROVATRIPTAN 9 in 1 BLISTER PACK TABLET, FILM COATED 9 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50742-299 FROVATRIPTAN (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20241215_92c91060-c06e-4a8a-b586-a3fb25c33433.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 50742-299-09 50742029909 1 BLISTER PACK in 1 CARTON (50742-299-09) / 9 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2022-07-22 0000-00-00 No No Current