Home NDC 64980-660 sumatriptan
Product NDC 64980-660
11-digit product format 649800660
Labeler code 64980
Product ID 64980-660_44569522-5e18-4e73-bb20-cac2c0f7a12f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sumatriptan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA219036
Marketing category ANDA
Marketing start 2025-05-05
Substance SUMATRIPTAN SUCCINATE
Active strength 25 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 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219036-001 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 A219036-002 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 A219036-003 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2026-08-18 06:07:40 2026-07 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base sumatriptan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUMATRIPTAN SUCCINATE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J8BDZ68989 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313160 Internal RxNorm lookup 313161 Internal RxNorm lookup 315223 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 64980-660-27 sumatriptan 3 in 1 CARTON TABLET, FILM COATED 3 2 64980-660-27 sumatriptan 9 in 1 BLISTER PACK TABLET, FILM COATED 9 2 64980-660-36 sumatriptan 36 in 1 BOTTLE TABLET, FILM COATED 36 2 64980-660-91 sumatriptan 1 in 1 CARTON TABLET, FILM COATED 1 2 64980-660-91 sumatriptan 9 in 1 BLISTER PACK TABLET, FILM COATED 9 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-660 SUMATRIPTAN TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] 1 Current NDC, 5 package rows 20250510_352d2ab3-d2c7-48c8-bcd4-d46ed9bdfa85.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 64980-660-27 64980066027 3 BLISTER PACK in 1 CARTON (64980-660-27) / 9 TABLET, FILM COATED in 1 BLISTER PACK 3 blister pack 2025-05-05 No No Current 64980-660-36 64980066036 36 TABLET, FILM COATED in 1 BOTTLE (64980-660-36) 2025-07-23 No No Current 64980-660-91 64980066091 1 BLISTER PACK in 1 CARTON (64980-660-91) / 9 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2025-05-05 No No Current