FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
68382-806
11-digit product format
683820806
Labeler code
68382
Product ID
68382-806_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
100 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 HYDROCHLORIDE100 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
68382-806-01Trazodone Hydrochloride100 in 1 BOTTLETABLET1009
68382-806-05Trazodone Hydrochloride500 in 1 BOTTLETABLET5009
68382-806-06Trazodone Hydrochloride30 in 1 BOTTLETABLET309
68382-806-10Trazodone Hydrochloride1000 in 1 BOTTLETABLET10009
68382-806-16Trazodone Hydrochloride90 in 1 BOTTLETABLET909
68382-806-30Trazodone Hydrochloride10 in 1 BLISTER PACKTABLET109
68382-806-77Trazodone Hydrochloride10 in 1 CARTONTABLET109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-806-01EA - Each68382-8066c63d3fb-96bd-45e4-91a5-e4f9d5a9e26312018-03-08
68382-806-05EA - Each68382-806de2fe365-4aba-4b44-ae4c-99f9a9f5f5c712018-03-08
68382-806-10EA - Each68382-8066fbc889f-31db-40b8-b13a-9cfa34f2a62c12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-806TRAZODONE 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
856373traZODone HCl 100 MG Oral TabletPSN9df17765-5d41-4e26-98de-850658114534104
856373trazodone hydrochloride 100 MG Oral TabletSCD9df17765-5d41-4e26-98de-850658114534104
856373traZODone HCl 100 MG Oral TabletPSN0545507a-5c11-4451-872a-d2f7f0aaecd417
856373trazodone hydrochloride 100 MG Oral TabletSCD0545507a-5c11-4451-872a-d2f7f0aaecd417
856373traZODone HCl 100 MG Oral TabletPSN614f2c6e-0bb7-43e0-85d8-5eef8eeae20812
856373trazodone hydrochloride 100 MG Oral TabletSCD614f2c6e-0bb7-43e0-85d8-5eef8eeae20812
856373traZODone HCl 100 MG Oral TabletPSN353e66cc-98ca-4500-97e7-00f23f12234911
856373trazodone hydrochloride 100 MG Oral TabletSCD353e66cc-98ca-4500-97e7-00f23f12234911
856373traZODone HCl 100 MG Oral TabletPSN8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856373traZODone HCl 100 MG Oral TabletPSN704aebf9-2fff-4ef3-8323-9ff0d7f0ffd99
856364traZODone HCl 150 MG Oral TabletPSN8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856364traZODone HCl 150 MG Oral TabletPSN704aebf9-2fff-4ef3-8323-9ff0d7f0ffd99
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 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 TabletSCD8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856377trazodone hydrochloride 50 MG Oral TabletSCD704aebf9-2fff-4ef3-8323-9ff0d7f0ffd99
856373traZODone HCl 100 MG Oral TabletPSN67d2a90a-3036-409c-aa32-937c550765478
856373trazodone hydrochloride 100 MG Oral TabletSCD67d2a90a-3036-409c-aa32-937c550765478
856373traZODone HCl 100 MG Oral TabletPSN6aaf08aa-9aa3-aabd-e053-2a91aa0a86d17
856373trazodone hydrochloride 100 MG Oral TabletSCD6aaf08aa-9aa3-aabd-e053-2a91aa0a86d17
856373traZODone HCl 100 MG Oral TabletPSN81a5b557-06f6-2470-e053-2991aa0a64fd6
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 TabletSCD81a5b557-06f6-2470-e053-2991aa0a64fd6
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
856373traZODone HCl 100 MG Oral TabletPSN907e01f8-0304-5d46-e053-2a95a90adcb84
856373trazodone hydrochloride 100 MG Oral TabletSCD907e01f8-0304-5d46-e053-2a95a90adcb84
856373traZODone HCl 100 MG Oral TabletPSNb716575a-5b96-49c5-bcb2-56b05fbb79203
856373traZODone HCl 100 MG Oral TabletPSN85bb3f78-5cf2-1319-e053-2991aa0ade753
856373trazodone hydrochloride 100 MG Oral TabletSCD85bb3f78-5cf2-1319-e053-2991aa0ade753
856373trazodone hydrochloride 100 MG Oral TabletSCDb716575a-5b96-49c5-bcb2-56b05fbb79203
856373traZODone HCl 100 MG Oral TabletPSN68bcae4b-f4c3-4d28-af76-d182b707fc732
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 TabletPSN04a676ee-358e-484d-9de4-a9a88d908ba82
856373trazodone hydrochloride 100 MG Oral TabletSCD04a676ee-358e-484d-9de4-a9a88d908ba82
856373trazodone hydrochloride 100 MG Oral TabletSCD68bcae4b-f4c3-4d28-af76-d182b707fc732
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 TabletSCD04a676ee-358e-484d-9de4-a9a88d908ba82
856373traZODone HCl 100 MG Oral TabletPSN3d202c55-2a44-4694-8083-a35bf2b627c81
856373traZODone HCl 100 MG Oral TabletPSN290242ec-030b-4b03-e063-6294a90a15191
856373traZODone HCl 100 MG Oral TabletPSN55779b6d-c43e-4b62-8b03-ff037c9a4a201
856373traZODone HCl 100 MG Oral TabletPSNac678c51-b1d3-4d6b-9599-7ef565b469d21
856373traZODone HCl 100 MG Oral TabletPSNa83588b7-d74b-4aa2-ab82-c2e8d32627a21
856373trazodone hydrochloride 100 MG Oral TabletSCD55779b6d-c43e-4b62-8b03-ff037c9a4a201
856373trazodone hydrochloride 100 MG Oral TabletSCDac678c51-b1d3-4d6b-9599-7ef565b469d21
856373trazodone hydrochloride 100 MG Oral TabletSCDa83588b7-d74b-4aa2-ab82-c2e8d32627a21
856373trazodone hydrochloride 100 MG Oral TabletSCD290242ec-030b-4b03-e063-6294a90a15191
856373trazodone hydrochloride 100 MG Oral TabletSCD3d202c55-2a44-4694-8083-a35bf2b627c81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-806-0168382080601100 TABLET in 1 BOTTLE (68382-806-01) 100 tablet2017-12-112028-12-31NoNoCurrent
68382-806-0568382080605500 TABLET in 1 BOTTLE (68382-806-05) 500 tablet2017-12-112028-12-31NoNoCurrent
68382-806-066838208060630 TABLET in 1 BOTTLE (68382-806-06) 30 tablet2017-12-112028-12-31NoNoCurrent
68382-806-10683820806101000 TABLET in 1 BOTTLE (68382-806-10) 1000 tablet2017-12-112028-12-31NoNoCurrent
68382-806-166838208061690 TABLET in 1 BOTTLE (68382-806-16) 90 tablet2017-12-112028-12-31NoNoCurrent
68382-806-306838208063010 in 1 BLISTER PACKHistorical
68382-806-776838208067710 BLISTER PACK in 1 CARTON (68382-806-77) / 10 TABLET in 1 BLISTER PACK (68382-806-30) 10 blister pack2017-12-112028-12-31NoNoCurrent