Home NDC 0378-5632 Sumatriptan Succinate
Product NDC 0378-5632
11-digit product format 003785632
Labeler code 0378
Product ID 0378-5632_cd918be8-d6c0-4dcc-aa7d-32bd7017fa1d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sumatriptan succinate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA077744
Marketing category ANDA
Marketing start 2009-08-10
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 2027-12-31
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0378-5632 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 0378-5632 0378-5632-11 UNFINISHED Active or certified unfinished drug listing 2026-08-17
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 · 38 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 0378-5632-11 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 0378-5632-11 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 0378-5632-11 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 0378-5632-11 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 0378-5632-11 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 0378-5632-11 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 0378-5632-11 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 0378-5632-11 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 0378-5632-11 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 0378-5632-11 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 0378-5632-11 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 0378-5632-11 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 0378-5632-11 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 0378-5632-11 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 0378-5632-11 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 0378-5632-11 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 unfinished product product 8fc7167e32ce…e96bbc724034…2021-02-18 23:40 UTC · source 2021-02-18 unfinished package package 0378-5632-11 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 unfinished product product 4184dd79f89f…545327b3e20f…2020-12-18 03:04 UTC · source 2020-12-17 unfinished package package 0378-5632-11 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished product product 4bd3596a7b87…5c64c6f6865f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished package package 0378-5632-11 4bd3596a7b87…5c64c6f6865f…
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 A077744-001 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 A077744-002 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 A077744-003 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10
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.
Product history page 1 of 4 · 126 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 A077744-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077744-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077744-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077744-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077744-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077744-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077744-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077744-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077744-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077744-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077744-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077744-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077744-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077744-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077744-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077744-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077744-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077744-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077744-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077744-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077744-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077744-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077744-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077744-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077744-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077744-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077744-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077744-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077744-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077744-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077744-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077744-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077744-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077744-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077744-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077744-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077744-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077744-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077744-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077744-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sumatriptan Succinate
Listing expiration 2027-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0378-5632-59 Sumatriptan Succinate 9 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 9 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SUMATRIPTAN SUCCINATE ACTIVE INGREDIENT J8BDZ68989 SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 SUMATRIPTAN ACTIVE MOIETY 8R78F6L9VO SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 POVIDONES INACTIVE INGREDIENT FZ989GH94E SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-5632 SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 14 Current NDC, Legacy NDC, 1 package rows 20230801_1d2cd01c-05e7-44cf-a71d-0f474e826b7e.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 Marketing start Marketing end Sample Exclude flag Status 0378-5632-11 00378563211 25000000 TABLET, FILM COATED in 1 DRUM (0378-5632-11) 10-AUG-09 Current 0378-5632-59 00378563259 9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5632-59) 2009-08-10 0000-00-00 No No Current