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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205253-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-10
A205253-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-10
A205253-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-10
A205253-004TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A205253-001AB
A205253-002AB
A205253-003AB
A205253-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-10a50c72e98297…
2026-08-01 22:54:322026-06A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-10a50c72e98297…
2026-08-01 22:54:322026-06A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-10a50c72e98297…
2026-08-01 22:54:322026-06A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205253-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205253-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A205253-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A205253-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.2863317d-657b-4dc6-81fb-b7158ea034982026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEA-S Medication Solutions007f38e0-653b-43e4-a1c1-b59997b2762a2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepack68bcae4b-f4c3-4d28-af76-d182b707fc732026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAmerican Health Packagingf715085a-be56-497e-ad92-9fec3aba70b52026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.614f2c6e-0bb7-43e0-85d8-5eef8eeae2082026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.04c287ca-5efa-469d-ab39-ff16d9b1e0b32026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy6aaf08aa-9aa3-aabd-e053-2a91aa0a86d12026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.0545507a-5c11-4451-872a-d2f7f0aaecd42026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.a31d59ed-5949-4f85-8b73-3bfd7f72d5b82026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEA-S Medication Solutions51e1ef06-d2c8-46db-a2b4-f20d4cc1abf32026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEA-S Medication Solutions297cdf27-5b6e-4665-93f9-8fc6aef483a02026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEZydus Lifesciences Limited43d4be17-5fae-4326-a5c4-9e25e2db6a432026-01-23Exact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.704aebf9-2fff-4ef3-8323-9ff0d7f0ffd92026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
ndc (product): 68382-806
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEA-S Medication Solutions4fcd25d5-e34f-4eea-aeff-aa442651e6812026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAvPAK9f1c2bf1-5204-7306-e053-2a95a90a99032026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEA-S Medication Solutions353e66cc-98ca-4500-97e7-00f23f1223492026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCb716575a-5b96-49c5-bcb2-56b05fbb79202025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAmerican Health Packaging094ca37b-3ae2-4889-9536-e7e5f20e31052025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPreferred Pharmaceuticals Inc.bb3ecde6-72ca-450c-ba88-9cf45c808d902025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPreferred Pharmaceuticals Inc.67d2a90a-3036-409c-aa32-937c550765472025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAZODONE HYDROCHLORIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6E8ZO8LRNMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856364Internal RxNorm lookup
856369Internal RxNorm lookup
856373Internal RxNorm lookup
856377Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9Available on FDA.report

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