FDA.reportPublic FDA data

Sumatriptan and Naproxen Sodium

Product NDC
16714-891
11-digit product format
167140891
Labeler code
16714
Product ID
16714-891_c5920565-605b-45cb-8da9-4d418ec3b356
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan and Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA202803
Marketing category
ANDA
Marketing start
2018-11-27
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
16714-891-01Sumatriptan and Naproxen Sodium9 in 1 BOTTLETABLET, FILM COATED96

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-891-01EA - Each16714-891931aa19e-3889-4b15-bc6d-29f203e9f91112019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-891SUMATRIPTAN AND NAPROXEN SODIUM TABLET, FILM COATED [NORTHSTAR RXLLC]5Current NDC, Legacy NDC, 1 package rows20250109_3f2ec27e-0e96-4028-a1fa-114e6d501464.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849450SUMAtriptan 85 MG / naproxen sodium 500 MG Oral TabletPSN3f2ec27e-0e96-4028-a1fa-114e6d5014646
849450naproxen sodium 500 MG / sumatriptan 85 MG Oral TabletSCD3f2ec27e-0e96-4028-a1fa-114e6d5014646
849450naproxen sodium 500 MG / sumatriptan (as sumatriptan succinate) 85 MG Oral TabletSY3f2ec27e-0e96-4028-a1fa-114e6d5014646

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-891-01167140891019 TABLET, FILM COATED in 1 BOTTLE (16714-891-01) 2018-11-270000-00-00NoNoCurrent