FDA.reportPublic FDA data

TREXIMET

Product NDC
21695-954
11-digit product format
216950954
Labeler code
21695
Product ID
21695-954_e08d5f22-f9c3-4627-8e5a-72c95183cf6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan succinate and naproxen sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021926
Marketing category
NDA
Marketing start
2008-04-25
Marketing end
0000-00-00
Substance
SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM
Active strength
85 mg/1; mg/1
Pharmacologic classes
Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
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
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877cProduct name120160303
49615343-b619-4365-8118-8f2ed6046e78Product name120160224
a6319377-430a-43db-82f9-30d1d9d89cf8Product name120151216
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-954-092019-09-24C16284748780-1934fe258-4917-48b1-e053-8cdaa90a720aTREXIMET ® (sumatriptan and naproxen sodium) Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-954-09TREXIMET9 in 1 CONTAINERTABLET, FILM COATED91

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-954-09EA - Each21695-9548ce5088e-2502-4d86-80a9-0dae6fd24cef12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CTREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
NAPROXENACTIVE MOIETY57Y76R9ATQTREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SUMATRIPTANACTIVE MOIETY8R78F6L9VOTREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JTREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GTREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ETREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOTREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-954TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110914_e08d5f22-f9c3-4627-8e5a-72c95183cf6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849450SUMAtriptan 85 MG / naproxen sodium 500 MG Oral TabletPSNe08d5f22-f9c3-4627-8e5a-72c95183cf6a1
849452Treximet 85 MG / 500 MG Oral TabletPSNe08d5f22-f9c3-4627-8e5a-72c95183cf6a1
849452naproxen sodium 500 MG / sumatriptan 85 MG Oral Tablet [Treximet]SBDe08d5f22-f9c3-4627-8e5a-72c95183cf6a1
849450naproxen sodium 500 MG / sumatriptan 85 MG Oral TabletSCDe08d5f22-f9c3-4627-8e5a-72c95183cf6a1
849450naproxen sodium 500 MG / sumatriptan (as sumatriptan succinate) 85 MG Oral TabletSYe08d5f22-f9c3-4627-8e5a-72c95183cf6a1
849452Treximet (naproxen sodium 500 MG / sumatriptan 85 MG (as sumatriptan succinate 119 MG)) Oral TabletSYe08d5f22-f9c3-4627-8e5a-72c95183cf6a1
849452Treximet 85/500 (sumitriptan / naproxen sodium) Oral TabletSYe08d5f22-f9c3-4627-8e5a-72c95183cf6a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-954-09216950954099 in 1 CONTAINERHistorical