FDA.reportPublic FDA data

Sumatriptan and Naproxen Sodium

Product NDC
47335-410
11-digit product format
473350410
Labeler code
47335
Product ID
47335-410_c67d3234-28c7-40a9-a472-87747bb4242a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan and Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA202803
Marketing category
ANDA
Marketing start
2018-07-20
Substance
NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Active strength
500; 85 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], 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 and Naproxen Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM500 mg/1
SUMATRIPTAN SUCCINATE85 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C, J8BDZ68989
Rxcui849450

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
2839c963-7eb3-970a-287f-ff1b6d381268Product name220250103
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
1e973b2d-e028-69cd-9258-4613ba80fdc5Product name320210512
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
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
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-410-22Sumatriptan and Naproxen Sodium9 in 1 BOTTLETABLET, FILM COATED915
47335-410-83Sumatriptan and Naproxen Sodium30 in 1 BOTTLETABLET, FILM COATED3015
47335-410-88Sumatriptan and Naproxen Sodium100 in 1 BOTTLETABLET, FILM COATED10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-410-22EA - Each47335-41077721bea-adc5-4044-813b-1655076d7a3012018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-410SUMATRIPTAN AND NAPROXEN SODIUM TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]14Current NDC, Legacy NDC, 3 package rows20241222_96ed12a3-fa76-4afd-bee8-1ab19eb607f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849450SUMAtriptan 85 MG / naproxen sodium 500 MG Oral TabletPSN96ed12a3-fa76-4afd-bee8-1ab19eb607f315
849450naproxen sodium 500 MG / sumatriptan 85 MG Oral TabletSCD96ed12a3-fa76-4afd-bee8-1ab19eb607f315
849450naproxen sodium 500 MG / sumatriptan (as sumatriptan succinate) 85 MG Oral TabletSY96ed12a3-fa76-4afd-bee8-1ab19eb607f315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-410-22473350410229 TABLET, FILM COATED in 1 BOTTLE (47335-410-22) 2018-07-200000-00-00NoNoCurrent
47335-410-834733504108330 TABLET, FILM COATED in 1 BOTTLE (47335-410-83) 2018-07-200000-00-00NoNoCurrent
47335-410-8847335041088100 TABLET, FILM COATED in 1 BOTTLE (47335-410-88) 2018-07-200000-00-00NoNoCurrent