FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
68382-807
11-digit product format
683820807
Labeler code
68382
Product ID
68382-807_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
Substance
TRAZODONE HYDROCHLORIDE
Active strength
150 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 HYDROCHLORIDE150 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
68382-807-01Trazodone Hydrochloride100 in 1 BOTTLETABLET1009
68382-807-05Trazodone Hydrochloride500 in 1 BOTTLETABLET5009
68382-807-06Trazodone Hydrochloride30 in 1 BOTTLETABLET309
68382-807-10Trazodone Hydrochloride1000 in 1 BOTTLETABLET10009
68382-807-16Trazodone Hydrochloride90 in 1 BOTTLETABLET909
68382-807-30Trazodone Hydrochloride10 in 1 BLISTER PACKTABLET109
68382-807-77Trazodone Hydrochloride10 in 1 CARTONTABLET109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-807-01EA - Each68382-807f541d095-2cdf-48d4-b22a-dc59e1e5126012018-03-08
68382-807-05EA - Each68382-8079335d8d7-844f-4650-a734-cf89a9faf69112018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-807TRAZODONE 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
856364traZODone HCl 150 MG Oral TabletPSN65ef34fb-8fe4-4e9d-9068-98702515ffeb103
856364trazodone hydrochloride 150 MG Oral TabletSCD65ef34fb-8fe4-4e9d-9068-98702515ffeb103
856364traZODone HCl 150 MG Oral TabletPSN4fcd25d5-e34f-4eea-aeff-aa442651e68111
856364trazodone hydrochloride 150 MG Oral TabletSCD4fcd25d5-e34f-4eea-aeff-aa442651e68111
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 TabletPSN8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856377traZODone HCl 50 MG Oral TabletPSN704aebf9-2fff-4ef3-8323-9ff0d7f0ffd99
856373trazodone hydrochloride 100 MG Oral TabletSCD8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856373trazodone hydrochloride 100 MG Oral TabletSCD704aebf9-2fff-4ef3-8323-9ff0d7f0ffd99
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 TabletSCD8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856377trazodone hydrochloride 50 MG Oral TabletSCD704aebf9-2fff-4ef3-8323-9ff0d7f0ffd99
856364traZODone HCl 150 MG Oral TabletPSN2863317d-657b-4dc6-81fb-b7158ea034988
856364traZODone HCl 150 MG Oral TabletPSNbb3ecde6-72ca-450c-ba88-9cf45c808d908
856364trazodone hydrochloride 150 MG Oral TabletSCD2863317d-657b-4dc6-81fb-b7158ea034988
856364trazodone hydrochloride 150 MG Oral TabletSCDbb3ecde6-72ca-450c-ba88-9cf45c808d908
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
856364traZODone HCl 150 MG Oral TabletPSN9f1c2bf1-5204-7306-e053-2a95a90a99035
856364trazodone hydrochloride 150 MG Oral TabletSCD9f1c2bf1-5204-7306-e053-2a95a90a99035
856364traZODone HCl 150 MG Oral TabletPSN66da652a-72b4-c17f-e053-2a91aa0a8d693
856377traZODone HCl 50 MG Oral TabletPSN66da652a-72b4-c17f-e053-2a91aa0a8d693
856364trazodone hydrochloride 150 MG Oral TabletSCD66da652a-72b4-c17f-e053-2a91aa0a8d693
856377trazodone hydrochloride 50 MG Oral TabletSCD66da652a-72b4-c17f-e053-2a91aa0a8d693
856373traZODone HCl 100 MG Oral TabletPSN04a676ee-358e-484d-9de4-a9a88d908ba82
856364traZODone HCl 150 MG Oral TabletPSN04a676ee-358e-484d-9de4-a9a88d908ba82
856364traZODone HCl 150 MG Oral TabletPSN8fed1f86-49ab-4747-e053-2a95a90a42b82
856364traZODone HCl 150 MG Oral TabletPSN907d088e-b469-3c34-e053-2a95a90a257a2
856369traZODone HCl 300 MG Oral TabletPSN04a676ee-358e-484d-9de4-a9a88d908ba82
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
856364trazodone hydrochloride 150 MG Oral TabletSCD8fed1f86-49ab-4747-e053-2a95a90a42b82
856364trazodone hydrochloride 150 MG Oral TabletSCD907d088e-b469-3c34-e053-2a95a90a257a2
856369trazodone hydrochloride 300 MG Oral TabletSCD04a676ee-358e-484d-9de4-a9a88d908ba82
856377trazodone hydrochloride 50 MG Oral TabletSCD04a676ee-358e-484d-9de4-a9a88d908ba82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-807-0168382080701100 TABLET in 1 BOTTLE (68382-807-01) 100 tablet2017-12-110000-00-00NoNoCurrent
68382-807-0568382080705500 TABLET in 1 BOTTLE (68382-807-05) 500 tablet2017-12-110000-00-00NoNoCurrent
68382-807-066838208070630 TABLET in 1 BOTTLE (68382-807-06) 30 tablet2017-12-110000-00-00NoNoCurrent
68382-807-10683820807101000 TABLET in 1 BOTTLE (68382-807-10) 1000 tablet2017-12-110000-00-00NoNoCurrent
68382-807-166838208071690 TABLET in 1 BOTTLE (68382-807-16) 90 tablet2017-12-110000-00-00NoNoCurrent
68382-807-306838208073010 in 1 BLISTER PACKHistorical
68382-807-776838208077710 BLISTER PACK in 1 CARTON (68382-807-77) / 10 TABLET in 1 BLISTER PACK (68382-807-30) 10 blister pack2017-12-110000-00-00NoNoCurrent