Sumatriptan

Product NDC
65862-147
11-digit product format
658620147
Labeler code
65862
Product ID
65862-147_e95a503d-623f-4736-ab25-a23fb9dd1994
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078327
Marketing category
ANDA
Marketing start
2009-08-17
Substance
SUMATRIPTAN SUCCINATE
Active strength
50 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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct65862-147UNFINISHEDActive or certified unfinished drug listing2026-08-12
unfinished packagepackage65862-14765862-147-26UNFINISHEDActive or certified unfinished drug listing2026-08-12

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 · 40 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-147-26a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-147-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-147-26390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-147-26e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-147-26bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-147-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-147-26f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-147-2668b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-147-2605c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-147-2648b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-147-2627f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-147-268d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-147-26d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-147-2650b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-147-26906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-147-266db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-147-268fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-147-264184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-147-264bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-147-26263afe128892…91768de4ddbe…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078327-001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10
A078327-002SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10
A078327-003SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078327-001AB
A078327-002AB
A078327-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-108072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078327-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078327-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078327-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078327-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078327-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078327-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078327-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078327-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078327-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078327-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078327-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078327-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078327-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078327-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078327-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078327-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Sumatriptan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN SUCCINATE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J8BDZ68989Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313160Internal RxNorm lookup
313161Internal RxNorm lookup
315223Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b2503fff-c978-4efa-b1b4-d7740b6b26f2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
2839c963-7eb3-970a-287f-ff1b6d381268Product name220250103
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
1e973b2d-e028-69cd-9258-4613ba80fdc5Product name320210512
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
3eb481d3-8b69-436f-82dd-4a66345568abProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877cProduct name120160303
49615343-b619-4365-8118-8f2ed6046e78Product name120160224
a6319377-430a-43db-82f9-30d1d9d89cf8Product name120151216
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-147-36Sumatriptan1 in 1 CARTONTABLET118
65862-147-36Sumatriptan9 in 1 BLISTER PACKTABLET918
65862-147-59Sumatriptan36 in 1 BOTTLETABLET3618

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-147-36EA - Each65862-14777301bef-a3dc-4d68-ae67-278d061de8ae12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]10
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]10
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]10
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]10
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [PREFERRED PHARMACEUTICALS, INC.]1
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [PREFERRED PHARMACEUTICALS, INC.]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [PREFERRED PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [PREFERRED PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [PREFERRED PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [PREFERRED PHARMACEUTICALS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [PREFERRED PHARMACEUTICALS, INC.]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [PREFERRED PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-147SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]16Current NDC, Legacy NDC, 3 package rows20240131_b2503fff-c978-4efa-b1b4-d7740b6b26f2.zip
65862-147MIGRAINE PACK (SUMATRIPTAN SUCCINATE, MENTHOLUM, BELLADONNA, IRIS VERSICOLOR, SANGUINARIA CANADENSIS) KIT [TMIG INC]4Current NDC, Legacy NDC20170114_5bc8dfa8-1c57-4dad-b250-e4da5e492d2f.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SumatriptanSUMATRIPTAN SUCCINATEREMEDYREPACK INC.73c9ac06-b55e-41e0-90ec-deb250f37eb52026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEAurobindo Pharma Limitedb2503fff-c978-4efa-b1b4-d7740b6b26f22026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
ndc (product): 65862-147
SumatriptanSUMATRIPTAN SUCCINATESportpharm LLCd071aef6-a5bd-4f68-ba6d-03004466897c2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEA-S Medication Solutions62ba6fef-467a-4500-993c-51907f12a67c2026-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENorthStar Rx LLC84bfc4ba-4172-4adb-b963-4e0eb438c07a2026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals, Inc.f2e7d756-1e12-462a-a43f-a9d860b11ee82025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals, Inc.bf9fd9fe-095b-4478-bd2e-a5534af077612025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals Inc.baf37e8c-d414-4ca7-a366-97dc202372ff2025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals, Inc.2efd4269-5657-9669-e063-6394a90a583a2025-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals, Inc.2a96f37d-03f6-678c-e063-6394a90ae0c62024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTANAdvanced Rx of Tennessee, LLCf1a118cf-2179-572a-e053-2995a90acbb02024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEQuality Care Products, LLC5d1f3de0-684a-4092-be30-aa325ff20d042024-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEQuality Care Products, LLCda77dfc4-551c-4e0e-a65e-cb478f193cd92024-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTANAdvanced Rx Pharmacy of Tennessee, LLCf8c4bbfb-1586-4610-e053-6394a90a8f092024-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.54c6f8f4-5466-3988-e054-00144ff8d46c2024-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.933f6575-a4c4-0f65-e053-2a95a90ab9672024-06-19Exact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.85295be9-852d-4e21-e053-2991aa0a8a782024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LPfe09fab6-b9e3-469c-9a38-bcc343dcc8992023-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEAsclemed USA, Inc.77f9f135-e840-48f0-81e8-73e08433e7682022-10-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LPabbd2168-1523-4eb6-a75c-dc4d7d1b1c9b2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313160SUMAtriptan succinate 100 MG Oral TabletPSN62ba6fef-467a-4500-993c-51907f12a67c31
315223SUMAtriptan succinate 25 MG Oral TabletPSN62ba6fef-467a-4500-993c-51907f12a67c31
313161SUMAtriptan succinate 50 MG Oral TabletPSN62ba6fef-467a-4500-993c-51907f12a67c31
313160sumatriptan 100 MG Oral TabletSCD62ba6fef-467a-4500-993c-51907f12a67c31
315223sumatriptan 25 MG Oral TabletSCD62ba6fef-467a-4500-993c-51907f12a67c31
313161sumatriptan 50 MG Oral TabletSCD62ba6fef-467a-4500-993c-51907f12a67c31
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSY62ba6fef-467a-4500-993c-51907f12a67c31
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY62ba6fef-467a-4500-993c-51907f12a67c31
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY62ba6fef-467a-4500-993c-51907f12a67c31
313160SUMAtriptan succinate 100 MG Oral TabletPSNb2503fff-c978-4efa-b1b4-d7740b6b26f218
315223SUMAtriptan succinate 25 MG Oral TabletPSNb2503fff-c978-4efa-b1b4-d7740b6b26f218
313161SUMAtriptan succinate 50 MG Oral TabletPSNb2503fff-c978-4efa-b1b4-d7740b6b26f218
313160sumatriptan 100 MG Oral TabletSCDb2503fff-c978-4efa-b1b4-d7740b6b26f218
315223sumatriptan 25 MG Oral TabletSCDb2503fff-c978-4efa-b1b4-d7740b6b26f218
313161sumatriptan 50 MG Oral TabletSCDb2503fff-c978-4efa-b1b4-d7740b6b26f218
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSYb2503fff-c978-4efa-b1b4-d7740b6b26f218
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSYb2503fff-c978-4efa-b1b4-d7740b6b26f218
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYb2503fff-c978-4efa-b1b4-d7740b6b26f218
313161SUMAtriptan succinate 50 MG Oral TabletPSNf2e7d756-1e12-462a-a43f-a9d860b11ee810
313161sumatriptan 50 MG Oral TabletSCDf2e7d756-1e12-462a-a43f-a9d860b11ee810
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYf2e7d756-1e12-462a-a43f-a9d860b11ee810
313160SUMAtriptan succinate 100 MG Oral TabletPSN9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
315223SUMAtriptan succinate 25 MG Oral TabletPSN9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
313161SUMAtriptan succinate 50 MG Oral TabletPSN9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
313160sumatriptan 100 MG Oral TabletSCD9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
315223sumatriptan 25 MG Oral TabletSCD9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
313161sumatriptan 50 MG Oral TabletSCD9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSY9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
313161SUMAtriptan succinate 50 MG Oral TabletPSN1042b91c-715c-4e90-b9cc-d91a17f9f7cb5
313161sumatriptan 50 MG Oral TabletSCD1042b91c-715c-4e90-b9cc-d91a17f9f7cb5
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY1042b91c-715c-4e90-b9cc-d91a17f9f7cb5
313161SUMAtriptan succinate 50 MG Oral TabletPSN5bc8dfa8-1c57-4dad-b250-e4da5e492d2f4
313161SUMAtriptan succinate 50 MG Oral TabletPSN54c6f8f4-5466-3988-e054-00144ff8d46c4
313161SUMAtriptan succinate 50 MG Oral TabletPSN80282282-057f-4c99-9017-5280829313f74
313161sumatriptan 50 MG Oral TabletSCD5bc8dfa8-1c57-4dad-b250-e4da5e492d2f4
313161sumatriptan 50 MG Oral TabletSCD80282282-057f-4c99-9017-5280829313f74
313161sumatriptan 50 MG Oral TabletSCD54c6f8f4-5466-3988-e054-00144ff8d46c4
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY80282282-057f-4c99-9017-5280829313f74
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY54c6f8f4-5466-3988-e054-00144ff8d46c4
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY5bc8dfa8-1c57-4dad-b250-e4da5e492d2f4
313161SUMAtriptan succinate 50 MG Oral TabletPSNda77dfc4-551c-4e0e-a65e-cb478f193cd93
313161SUMAtriptan succinate 50 MG Oral TabletPSN85295be9-852d-4e21-e053-2991aa0a8a783
313161sumatriptan 50 MG Oral TabletSCD85295be9-852d-4e21-e053-2991aa0a8a783
313161sumatriptan 50 MG Oral TabletSCDda77dfc4-551c-4e0e-a65e-cb478f193cd93
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYda77dfc4-551c-4e0e-a65e-cb478f193cd93
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY85295be9-852d-4e21-e053-2991aa0a8a783
313160SUMAtriptan succinate 100 MG Oral TabletPSNd071aef6-a5bd-4f68-ba6d-03004466897c2
315223SUMAtriptan succinate 25 MG Oral TabletPSNd071aef6-a5bd-4f68-ba6d-03004466897c2
313161SUMAtriptan succinate 50 MG Oral TabletPSNf8c4bbfb-1586-4610-e053-6394a90a8f092
313161SUMAtriptan succinate 50 MG Oral TabletPSNd071aef6-a5bd-4f68-ba6d-03004466897c2
313160sumatriptan 100 MG Oral TabletSCDd071aef6-a5bd-4f68-ba6d-03004466897c2
315223sumatriptan 25 MG Oral TabletSCDd071aef6-a5bd-4f68-ba6d-03004466897c2
313161sumatriptan 50 MG Oral TabletSCDf8c4bbfb-1586-4610-e053-6394a90a8f092
313161sumatriptan 50 MG Oral TabletSCDd071aef6-a5bd-4f68-ba6d-03004466897c2
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSYd071aef6-a5bd-4f68-ba6d-03004466897c2
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSYd071aef6-a5bd-4f68-ba6d-03004466897c2
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYf8c4bbfb-1586-4610-e053-6394a90a8f092
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYd071aef6-a5bd-4f68-ba6d-03004466897c2
209169IMITREX 50 MG Oral TabletPSN34b663e0-e40c-366f-e054-00144ff8d46c1
313160SUMAtriptan succinate 100 MG Oral TabletPSN77f9f135-e840-48f0-81e8-73e08433e7681
315223SUMAtriptan succinate 25 MG Oral TabletPSN77f9f135-e840-48f0-81e8-73e08433e7681
313161SUMAtriptan succinate 50 MG Oral TabletPSNa1b60c11-9c87-4400-86dd-2c28284298d91
313161SUMAtriptan succinate 50 MG Oral TabletPSN77f9f135-e840-48f0-81e8-73e08433e7681
313161SUMAtriptan succinate 50 MG Oral TabletPSN34b663e0-e40c-366f-e054-00144ff8d46c1
209169sumatriptan 50 MG Oral Tablet [Imitrex]SBD34b663e0-e40c-366f-e054-00144ff8d46c1
313160sumatriptan 100 MG Oral TabletSCD77f9f135-e840-48f0-81e8-73e08433e7681
315223sumatriptan 25 MG Oral TabletSCD77f9f135-e840-48f0-81e8-73e08433e7681
313161sumatriptan 50 MG Oral TabletSCD77f9f135-e840-48f0-81e8-73e08433e7681
313161sumatriptan 50 MG Oral TabletSCDa1b60c11-9c87-4400-86dd-2c28284298d91
313161sumatriptan 50 MG Oral TabletSCD34b663e0-e40c-366f-e054-00144ff8d46c1
209169Imitrex 50 MG (sumatriptan succinate 70 MG) Oral TabletSY34b663e0-e40c-366f-e054-00144ff8d46c1
209169Imitrex 50 MG Oral TabletSY34b663e0-e40c-366f-e054-00144ff8d46c1
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSY77f9f135-e840-48f0-81e8-73e08433e7681
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY77f9f135-e840-48f0-81e8-73e08433e7681
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYa1b60c11-9c87-4400-86dd-2c28284298d91
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY34b663e0-e40c-366f-e054-00144ff8d46c1
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY77f9f135-e840-48f0-81e8-73e08433e7681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-147-26658620147262500 TABLET in 1 BAG (65862-147-26)2500 tablet17-AUG-09Current
65862-147-36658620147361 BLISTER PACK in 1 CARTON (65862-147-36) / 9 TABLET in 1 BLISTER PACK1 blister pack2009-08-170000-00-00NoNoCurrent
65862-147-596586201475936 TABLET in 1 BOTTLE (65862-147-59) 36 tablet2022-06-220000-00-00NoNoCurrent