FDA.reportPublic FDA data

Sumatriptan Succinate

Product NDC
43598-768
11-digit product format
435980768
Labeler code
43598
Product ID
43598-768_d0cf8002-71d2-7e4b-f04e-0120cc95dc1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Dr. Reddy�s Laboratories Inc.,
Application
ANDA090495
Marketing category
ANDA
Marketing start
2023-04-20
Substance
SUMATRIPTAN SUCCINATE
Active strength
6 mg/.5mL
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN SUCCINATE6 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ8BDZ68989
Rxcui1657151

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-768-11Sumatriptan Succinate0.5 mL in 1 SYRINGEINJECTION0.53
43598-768-23Sumatriptan Succinate2 in 1 CARTONINJECTION23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-768-11ML - Milliliter43598-7680fa2a1ac-4243-47be-b001-cb950111a5d012023-07-06
43598-768-23ML - Milliliter43598-7685162f6d8-e571-43fb-b078-c0313a182edc12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-768SUMATRIPTAN SUCCINATE INJECTION [DR. REDDY’S LABORATORIES INC.,]2Current NDC, 2 package rows20240802_8fef1176-7a38-eca3-22ca-83efe5ca6620.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1657151SUMAtriptan 6 MG in 0.5 ML Auto-InjectorPSN8fef1176-7a38-eca3-22ca-83efe5ca66203
16571510.5 ML sumatriptan 12 MG/ML Auto-InjectorSCD8fef1176-7a38-eca3-22ca-83efe5ca66203
1657151sumatriptan (as sumatriptan succinate) 6 MG per 0.5 ML Auto-InjectorSY8fef1176-7a38-eca3-22ca-83efe5ca66203

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-768-11435980768110.5 mL in 1 SYRINGE0.5 mlHistorical
43598-768-23435980768232 SYRINGE in 1 CARTON (43598-768-23) / .5 mL in 1 SYRINGE (43598-768-11) 2 syringe2023-04-20NoNoCurrent