sumatriptan succinate

Product NDC
62756-521
11-digit product format
627560521
Labeler code
62756
Product ID
62756-521_9035f04f-b353-4883-9ac2-e030f18bfc1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078295
Marketing category
ANDA
Marketing start
2009-08-10
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
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078295-001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-10
A078295-002SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-10
A078295-003SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-08-10

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078295-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-10caaa826d4ba7…
2026-08-18 06:07:402026-07A078295-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-10caaa826d4ba7…
2026-08-18 06:07:402026-07A078295-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-08-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078295-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078295-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078295-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078295-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078295-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078295-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078295-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078295-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078295-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078295-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078295-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078295-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078295-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078295-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078295-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078295-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078295-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078295-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078295-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078295-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078295-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078295-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078295-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078295-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078295-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078295-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078295-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078295-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A078295-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A078295-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078295-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078295-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078295-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078295-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078295-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078295-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078295-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-101e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078295-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078295-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078295-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078295-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078295-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078295-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078295-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078295-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078295-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078295-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078295-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078295-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078295-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078295-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078295-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078295-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078295-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078295-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078295-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078295-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078295-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078295-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078295-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078295-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078295-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078295-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078295-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078295-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078295-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078295-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078295-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078295-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078295-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078295-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078295-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078295-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078295-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078295-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078295-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078295-001AB14b0b4de00fa7…

Additional Listing Data#

Finished product
Yes
Brand name base
sumatriptan succinate
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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9485cc30-15e8-4b53-876d-db317145474bAvailable 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
1e973b2d-e028-69cd-9258-4613ba80fdc5Product name320210512
3eb481d3-8b69-436f-82dd-4a66345568abProduct name120190611
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877cProduct name120160303
49615343-b619-4365-8118-8f2ed6046e78Product name120160224
a6319377-430a-43db-82f9-30d1d9d89cf8Product name120151216
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-521-69EA - Each62756-521ed3a1f8e-4511-4a83-92f8-23d243476e5912012-07-24
62756-521-88EA - Each62756-521d3b2f451-2b1f-4343-9d2b-f9568a0c01ed12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KSUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
TALCINACTIVE INGREDIENT7SEV7J4R1USUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN SUCCINATE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SUCCINATE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JSUMATRIPTAN SUCCINATE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JSUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN SUCCINATE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN SUCCINATE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUMATRIPTAN SUCCINATE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUMATRIPTAN SUCCINATE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSUMATRIPTAN SUCCINATE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSUMATRIPTAN SUCCINATE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUMATRIPTAN SUCCINATE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1USUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1USUMATRIPTAN SUCCINATE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSUMATRIPTAN SUCCINATE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-521SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]14Current NDC, Legacy NDC20240301_9485cc30-15e8-4b53-876d-db317145474b.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sumatriptan succinateSUMATRIPTAN SUCCINATESun Pharmaceutical Industries, Inc.9485cc30-15e8-4b53-876d-db317145474b2026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078295
application number: ANDA078295
ndc (product): 62756-521
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDirect_Rxf6c95873-576d-a1c2-e053-6294a90a3ff92025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078295
application number: ANDA078295
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDirect_Rxf6c907a3-9624-f893-e053-6294a90a31af2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078295
application number: ANDA078295
sumatriptan succinateSUMATRIPTAN SUCCINATEA-S Medication Solutions97016a59-3b49-4134-85aa-8c866f2856012023-11-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078295
application number: ANDA078295
sumatriptan succinateSUMATRIPTAN SUCCINATEProficient Rx LP9f4d487a-c5f7-4707-976b-64e738c98d452022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078295
application number: ANDA078295
sumatriptan succinateSUMATRIPTAN SUCCINATEProficient Rx LPd556563f-ad71-45c1-829a-cc11983bce0c2020-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078295
application number: ANDA078295

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313161SUMAtriptan succinate 50 MG Oral TabletPSNd556563f-ad71-45c1-829a-cc11983bce0c3
313161SUMAtriptan succinate 50 MG Oral TabletPSNf6c907a3-9624-f893-e053-6294a90a31af3
313161sumatriptan 50 MG Oral TabletSCDd556563f-ad71-45c1-829a-cc11983bce0c3
313161sumatriptan 50 MG Oral TabletSCDf6c907a3-9624-f893-e053-6294a90a31af3
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYd556563f-ad71-45c1-829a-cc11983bce0c3
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYf6c907a3-9624-f893-e053-6294a90a31af3
313161SUMAtriptan succinate 50 MG Oral TabletPSN4eadc265-78b3-473c-8a60-3f8e5c222dcf1
313161sumatriptan 50 MG Oral TabletSCD4eadc265-78b3-473c-8a60-3f8e5c222dcf1
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY4eadc265-78b3-473c-8a60-3f8e5c222dcf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-521-01627560521013 BLISTER PACK in 1 CARTON (62756-521-01) / 9 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2020-11-010000-00-00NoNoCurrent
62756-521-0862756052108100 TABLET, FILM COATED in 1 BOTTLE (62756-521-08) 2009-08-100000-00-00NoNoCurrent
62756-521-18627560521181000 TABLET, FILM COATED in 1 BOTTLE (62756-521-18) 2009-08-100000-00-00NoNoCurrent
62756-521-69627560521699 BLISTER PACK in 1 CARTON (62756-521-69) / 1 TABLET, FILM COATED in 1 BLISTER PACK9 blister pack2009-08-100000-00-00NoNoCurrent
62756-521-836275605218330 TABLET, FILM COATED in 1 BOTTLE (62756-521-83) 2009-08-100000-00-00NoNoCurrent
62756-521-8862756052188100 TABLET, FILM COATED in 1 BOTTLE (62756-521-88) 2009-08-100000-00-00NoNoCurrent
62756-521-93627560521939 BLISTER PACK in 1 CARTON (62756-521-93) / 1 TABLET, FILM COATED in 1 BLISTER PACK9 blister pack2009-08-100000-00-00NoNoCurrent