sumatriptan succinate

Product NDC
62756-522
11-digit product format
627560522
Labeler code
62756
Product ID
62756-522_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
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

Additional Listing Data#

Finished product
Yes
Brand name base
sumatriptan succinate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN SUCCINATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ8BDZ68989

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-522-69EA - Each62756-522bdc60901-091f-4f67-ba51-cab4f79b225412012-07-24
62756-522-88EA - Each62756-522456aa130-8a84-4432-a7fc-60192bb73bb712012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-522SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]14Current NDC, Legacy NDC20240301_9485cc30-15e8-4b53-876d-db317145474b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-522-01627560522013 BLISTER PACK in 1 CARTON (62756-522-01) / 9 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2020-11-010000-00-00NoNoCurrent
62756-522-0862756052208100 TABLET, FILM COATED in 1 BOTTLE (62756-522-08) 2009-08-100000-00-00NoNoCurrent
62756-522-18627560522181000 TABLET, FILM COATED in 1 BOTTLE (62756-522-18) 2009-08-100000-00-00NoNoCurrent
62756-522-69627560522699 BLISTER PACK in 1 CARTON (62756-522-69) / 1 TABLET, FILM COATED in 1 BLISTER PACK9 blister pack2009-08-100000-00-00NoNoCurrent
62756-522-836275605228330 TABLET, FILM COATED in 1 BOTTLE (62756-522-83) 2009-08-100000-00-00NoNoCurrent
62756-522-8862756052288100 TABLET, FILM COATED in 1 BOTTLE (62756-522-88) 2009-08-100000-00-00NoNoCurrent
62756-522-93627560522939 BLISTER PACK in 1 CARTON (62756-522-93) / 1 TABLET, FILM COATED in 1 BLISTER PACK9 blister pack2009-08-100000-00-00NoNoCurrent