FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
68382-805
11-digit product format
683820805
Labeler code
68382
Product ID
68382-805_24cb2e4c-a9ba-4283-8396-343f6aa03121
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA205253
Marketing category
ANDA
Marketing start
2017-12-11
Marketing end
2028-12-31
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride

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
68382-805-01Trazodone Hydrochloride100 in 1 BOTTLETABLET1009
68382-805-05Trazodone Hydrochloride500 in 1 BOTTLETABLET5009
68382-805-06Trazodone Hydrochloride30 in 1 BOTTLETABLET309
68382-805-10Trazodone Hydrochloride1000 in 1 BOTTLETABLET10009
68382-805-16Trazodone Hydrochloride90 in 1 BOTTLETABLET909
68382-805-30Trazodone Hydrochloride10 in 1 BLISTER PACKTABLET109
68382-805-77Trazodone Hydrochloride10 in 1 CARTONTABLET109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-805-01EA - Each68382-80513bb0c56-4202-4d5c-ab63-5fa1dac4427d12018-03-08
68382-805-05EA - Each68382-805061017ba-0d76-4cfd-9619-5743c441d68212018-03-08
68382-805-10EA - Each68382-8058c4f9c24-b287-41ef-81f2-e24be5e5eaf612018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-805TRAZODONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 7 package rows20250503_704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSN04c287ca-5efa-469d-ab39-ff16d9b1e0b315
856377trazodone hydrochloride 50 MG Oral TabletSCD04c287ca-5efa-469d-ab39-ff16d9b1e0b315
856377traZODone HCl 50 MG Oral TabletPSN42ecd35c-4300-4cd3-942a-f3efb872fa9913
856377trazodone hydrochloride 50 MG Oral TabletSCD42ecd35c-4300-4cd3-942a-f3efb872fa9913
856377traZODone HCl 50 MG Oral TabletPSNa31d59ed-5949-4f85-8b73-3bfd7f72d5b811
856377traZODone HCl 50 MG Oral TabletPSN3df90104-ef2c-4a82-b007-9843c43969ae11
856377trazodone hydrochloride 50 MG Oral TabletSCDa31d59ed-5949-4f85-8b73-3bfd7f72d5b811
856377trazodone hydrochloride 50 MG Oral TabletSCD3df90104-ef2c-4a82-b007-9843c43969ae11
856373traZODone HCl 100 MG Oral TabletPSN704aebf9-2fff-4ef3-8323-9ff0d7f0ffd99
856373traZODone HCl 100 MG Oral TabletPSN8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856364traZODone HCl 150 MG Oral TabletPSN704aebf9-2fff-4ef3-8323-9ff0d7f0ffd99
856364traZODone HCl 150 MG Oral TabletPSN8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856369traZODone HCl 300 MG Oral TabletPSN704aebf9-2fff-4ef3-8323-9ff0d7f0ffd99
856377traZODone HCl 50 MG Oral TabletPSN704aebf9-2fff-4ef3-8323-9ff0d7f0ffd99
856377traZODone HCl 50 MG Oral TabletPSN8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856377traZODone HCl 50 MG Oral TabletPSN6adb446d-cd2f-3d6b-e053-2991aa0a21149
856373trazodone hydrochloride 100 MG Oral TabletSCD704aebf9-2fff-4ef3-8323-9ff0d7f0ffd99
856373trazodone hydrochloride 100 MG Oral TabletSCD8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856364trazodone hydrochloride 150 MG Oral TabletSCD704aebf9-2fff-4ef3-8323-9ff0d7f0ffd99
856364trazodone hydrochloride 150 MG Oral TabletSCD8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856369trazodone hydrochloride 300 MG Oral TabletSCD704aebf9-2fff-4ef3-8323-9ff0d7f0ffd99
856377trazodone hydrochloride 50 MG Oral TabletSCD704aebf9-2fff-4ef3-8323-9ff0d7f0ffd99
856377trazodone hydrochloride 50 MG Oral TabletSCD8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856377trazodone hydrochloride 50 MG Oral TabletSCD6adb446d-cd2f-3d6b-e053-2991aa0a21149
856377traZODone HCl 50 MG Oral TabletPSN9962589c-ee1f-4d5e-bd49-b7807bb60ace8
856377trazodone hydrochloride 50 MG Oral TabletSCD9962589c-ee1f-4d5e-bd49-b7807bb60ace8
856373traZODone HCl 100 MG Oral TabletPSN094ca37b-3ae2-4889-9536-e7e5f20e31056
856364traZODone HCl 150 MG Oral TabletPSN094ca37b-3ae2-4889-9536-e7e5f20e31056
856377traZODone HCl 50 MG Oral TabletPSN094ca37b-3ae2-4889-9536-e7e5f20e31056
856373trazodone hydrochloride 100 MG Oral TabletSCD094ca37b-3ae2-4889-9536-e7e5f20e31056
856364trazodone hydrochloride 150 MG Oral TabletSCD094ca37b-3ae2-4889-9536-e7e5f20e31056
856377trazodone hydrochloride 50 MG Oral TabletSCD094ca37b-3ae2-4889-9536-e7e5f20e31056
856377traZODone HCl 50 MG Oral TabletPSNd27e4473-6f62-ddfe-e053-2a95a90a9a2c5
856377trazodone hydrochloride 50 MG Oral TabletSCDd27e4473-6f62-ddfe-e053-2a95a90a9a2c5
856377traZODone HCl 50 MG Oral TabletPSN907e236a-9cb5-5454-e053-2995a90aaaad4
856377trazodone hydrochloride 50 MG Oral TabletSCD907e236a-9cb5-5454-e053-2995a90aaaad4
856373traZODone HCl 100 MG Oral TabletPSN04a676ee-358e-484d-9de4-a9a88d908ba82
856364traZODone HCl 150 MG Oral TabletPSN04a676ee-358e-484d-9de4-a9a88d908ba82
856369traZODone HCl 300 MG Oral TabletPSN04a676ee-358e-484d-9de4-a9a88d908ba82
856377traZODone HCl 50 MG Oral TabletPSNf40e8e89-afac-6028-e053-2995a90a49b62
856377traZODone HCl 50 MG Oral TabletPSN6d3e37ca-6b55-4979-9a0a-e2cd0da1888f2
856377traZODone HCl 50 MG Oral TabletPSN88ac1a9d-8483-4b29-9fe6-2e60e51f30052
856377traZODone HCl 50 MG Oral TabletPSN04a676ee-358e-484d-9de4-a9a88d908ba82
856373trazodone hydrochloride 100 MG Oral TabletSCD04a676ee-358e-484d-9de4-a9a88d908ba82
856364trazodone hydrochloride 150 MG Oral TabletSCD04a676ee-358e-484d-9de4-a9a88d908ba82
856369trazodone hydrochloride 300 MG Oral TabletSCD04a676ee-358e-484d-9de4-a9a88d908ba82
856377trazodone hydrochloride 50 MG Oral TabletSCD88ac1a9d-8483-4b29-9fe6-2e60e51f30052
856377trazodone hydrochloride 50 MG Oral TabletSCD6d3e37ca-6b55-4979-9a0a-e2cd0da1888f2
856377trazodone hydrochloride 50 MG Oral TabletSCDf40e8e89-afac-6028-e053-2995a90a49b62
856377trazodone hydrochloride 50 MG Oral TabletSCD04a676ee-358e-484d-9de4-a9a88d908ba82
856377traZODone HCl 50 MG Oral TabletPSN007f38e0-653b-43e4-a1c1-b59997b2762a1
856377traZODone HCl 50 MG Oral TabletPSN12f1737b-c021-d0f2-e063-6294a90a6f291
856377traZODone HCl 50 MG Oral TabletPSN25de4131-3a94-e7d5-e063-6294a90a61bb1
856377traZODone HCl 50 MG Oral TabletPSN2d3f1d0b-3686-f4d7-e063-6394a90a1a761
856377trazodone hydrochloride 50 MG Oral TabletSCD12f1737b-c021-d0f2-e063-6294a90a6f291
856377trazodone hydrochloride 50 MG Oral TabletSCD25de4131-3a94-e7d5-e063-6294a90a61bb1
856377trazodone hydrochloride 50 MG Oral TabletSCD007f38e0-653b-43e4-a1c1-b59997b2762a1
856377trazodone hydrochloride 50 MG Oral TabletSCD2d3f1d0b-3686-f4d7-e063-6394a90a1a761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-805-0168382080501100 TABLET in 1 BOTTLE (68382-805-01) 100 tablet2017-12-112028-12-31NoNoCurrent
68382-805-0568382080505500 TABLET in 1 BOTTLE (68382-805-05) 500 tablet2017-12-112028-12-31NoNoCurrent
68382-805-066838208050630 TABLET in 1 BOTTLE (68382-805-06) 30 tablet2017-12-112028-12-31NoNoCurrent
68382-805-10683820805101000 TABLET in 1 BOTTLE (68382-805-10) 1000 tablet2017-12-112028-12-31NoNoCurrent
68382-805-166838208051690 TABLET in 1 BOTTLE (68382-805-16) 90 tablet2017-12-112028-12-31NoNoCurrent
68382-805-306838208053010 in 1 BLISTER PACKHistorical
68382-805-776838208057710 BLISTER PACK in 1 CARTON (68382-805-77) / 10 TABLET in 1 BLISTER PACK (68382-805-30) 10 blister pack2017-12-112028-12-31NoNoCurrent