Trazodone Hydrochloride

Product NDC
13668-330
11-digit product format
136680330
Labeler code
13668
Product ID
13668-330_bc2a4de4-8b05-4bb8-bf92-b7f5daa0a6f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA202180
Marketing category
ANDA
Marketing start
2013-11-27
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAZODONE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E8ZO8LRNM
Rxcui856364, 856369, 856373, 856377

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac7a3d9b-58c0-4ffc-a3eb-ed863453525eProduct name120250730
b2f15d64-48ea-ba98-af5c-91f410667b31Product name520250314
d8e7f61b-4ab5-0dbe-2706-4e11b6079b87Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-330-01Trazodone Hydrochloride100 in 1 BOTTLETABLET10013
13668-330-05Trazodone Hydrochloride500 in 1 BOTTLETABLET50013
13668-330-10Trazodone Hydrochloride1000 in 1 BOTTLETABLET100013
13668-330-30Trazodone Hydrochloride30 in 1 BOTTLETABLET3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-330-01EA - Each13668-330ad15d619-713b-4421-a9d2-f68fd05fa42d12014-02-04
13668-330-05EA - Each13668-33069f154ed-29b3-4484-9366-2e8e5feff30f12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]1
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJTRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-330TRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]10Current NDC, Legacy NDC, 4 package rows20250322_1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN1510cf89-a2ec-4ed5-80cb-bae84f9ec0a713
856364traZODone HCl 150 MG Oral TabletPSN1510cf89-a2ec-4ed5-80cb-bae84f9ec0a713
856369traZODone HCl 300 MG Oral TabletPSN1510cf89-a2ec-4ed5-80cb-bae84f9ec0a713
856377traZODone HCl 50 MG Oral TabletPSN1510cf89-a2ec-4ed5-80cb-bae84f9ec0a713
856373trazodone hydrochloride 100 MG Oral TabletSCD1510cf89-a2ec-4ed5-80cb-bae84f9ec0a713
856364trazodone hydrochloride 150 MG Oral TabletSCD1510cf89-a2ec-4ed5-80cb-bae84f9ec0a713
856369trazodone hydrochloride 300 MG Oral TabletSCD1510cf89-a2ec-4ed5-80cb-bae84f9ec0a713
856377trazodone hydrochloride 50 MG Oral TabletSCD1510cf89-a2ec-4ed5-80cb-bae84f9ec0a713
856377traZODone HCl 50 MG Oral TabletPSNf98b1e8f-9c66-3e9c-e053-6294a90ab0573
856377trazodone hydrochloride 50 MG Oral TabletSCDf98b1e8f-9c66-3e9c-e053-6294a90ab0573
856377traZODone HCl 50 MG Oral TabletPSN2a1d0989-6ed5-4a2f-bd03-73d61eb402322
856377traZODone HCl 50 MG Oral TabletPSNfc9b90d1-7da5-efc1-e053-6294a90a02232
856377traZODone HCl 50 MG Oral TabletPSNfa1c1bde-d65b-6163-e053-6394a90a3c2f2
856377trazodone hydrochloride 50 MG Oral TabletSCDfc9b90d1-7da5-efc1-e053-6294a90a02232
856377trazodone hydrochloride 50 MG Oral TabletSCDfa1c1bde-d65b-6163-e053-6394a90a3c2f2
856377trazodone hydrochloride 50 MG Oral TabletSCD2a1d0989-6ed5-4a2f-bd03-73d61eb402322
856377traZODone HCl 50 MG Oral TabletPSNadc7427e-3553-4805-b063-eeda840490291
856377traZODone HCl 50 MG Oral TabletPSN5bb98507-6c62-4892-b514-782209e680d11
856377trazodone hydrochloride 50 MG Oral TabletSCDadc7427e-3553-4805-b063-eeda840490291
856377trazodone hydrochloride 50 MG Oral TabletSCD5bb98507-6c62-4892-b514-782209e680d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-330-0113668033001100 TABLET in 1 BOTTLE (13668-330-01) 100 tablet2013-11-270000-00-00NoNoCurrent
13668-330-0513668033005500 TABLET in 1 BOTTLE (13668-330-05) 500 tablet2013-11-270000-00-00NoNoCurrent
13668-330-10136680330101000 TABLET in 1 BOTTLE (13668-330-10) 1000 tablet2013-11-270000-00-00NoNoCurrent
13668-330-301366803303030 TABLET in 1 BOTTLE (13668-330-30) 30 tablet2013-11-270000-00-00NoNoCurrent
13668-330-7413668033074100 TABLET in 1 CARTON (13668-330-74) 100 tablet2013-11-270000-00-00NoNoCurrent