Home NDC 63304-099 Sumatriptan
Product NDC 63304-099
11-digit product format 633040099
Labeler code 63304
Product ID 63304-099_9bc4f2da-41f0-42e2-98b2-b689c02d0a3e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sumatriptan
Dosage form TABLET
Route ORAL
Labeler SUN PHARMACEUTICAL INDUSTRIES, INC.
Application ANDA076572
Marketing category ANDA
Marketing start 2009-02-10
Substance SUMATRIPTAN SUCCINATE
Active strength 100 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 63304-099-13 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 63304-099-19 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 63304-099-45 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 63304-099-13 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 63304-099-19 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 63304-099-45 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63304-099-13 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63304-099-19 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63304-099-45 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 63304-099-13 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 63304-099-19 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 63304-099-45 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A076572-001 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09
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 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076572-001 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-02-09 e64feba35796…
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 100 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63304-099-13 2022-01-19 These highlights do not include all the information needed to use SUMATRIPTAN TABLETS, USP safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS, USP. SUMATRIPTAN tablets, USP, for oral use Initial U.S. Approval: 1992 63304-099-19 2022-01-19 These highlights do not include all the information needed to use SUMATRIPTAN TABLETS, USP safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS, USP. SUMATRIPTAN tablets, USP, for oral use Initial U.S. Approval: 1992 63304-099-45 2022-01-19 These highlights do not include all the information needed to use SUMATRIPTAN TABLETS, USP safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS, USP. SUMATRIPTAN tablets, USP, for oral use Initial U.S. Approval: 1992 63304-099-13 2020-01-31 These highlights do not include all the information needed to use SUMATRIPTAN TABLETS, USP safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS, USP. SUMATRIPTAN tablets, USP, for oral use Initial U.S. Approval: 1992 63304-099-19 2020-01-31 These highlights do not include all the information needed to use SUMATRIPTAN TABLETS, USP safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS, USP. SUMATRIPTAN tablets, USP, for oral use Initial U.S. Approval: 1992 63304-099-45 2020-01-31 These highlights do not include all the information needed to use SUMATRIPTAN TABLETS, USP safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS, USP. SUMATRIPTAN tablets, USP, for oral use Initial U.S. Approval: 1992
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63304-099-13 Sumatriptan 120 in 1 BOTTLE TABLET 120 7 63304-099-19 Sumatriptan 1 in 1 CARTON TABLET 1 7 63304-099-19 Sumatriptan 9 in 1 BLISTER PACK TABLET 9 7 63304-099-45 Sumatriptan 5 in 1 BOTTLE TABLET 5 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-099 SUMATRIPTAN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 Current NDC, Legacy NDC, 4 package rows 20220120_c87cf537-9f7f-400e-ac4b-86e6f7e78775.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 · 2 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 63304-099-13 63304009913 120 TABLET in 1 BOTTLE (63304-099-13) 120 tablet 2009-02-10 0000-00-00 No No Current 63304-099-19 63304009919 1 BLISTER PACK in 1 CARTON (63304-099-19) / 9 TABLET in 1 BLISTER PACK 1 blister pack 2009-02-10 0000-00-00 No No Current 63304-099-45 63304009945 5 TABLET in 1 BOTTLE (63304-099-45) 5 tablet 2009-02-10 0000-00-00 No No Current