Trazodone Hydrochloride

Product NDC
80425-0302
11-digit product format
804250302
Labeler code
80425
Product ID
80425-0302_2a9bfe6a-6d68-b262-e063-6294a90a1cf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA204852
Marketing category
ANDA
Marketing start
2023-04-10
Substance
TRAZODONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
A204852-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2020-02-05
A204852-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2020-02-05
A204852-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2020-02-05
A204852-004TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2020-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204852-001AB
A204852-002AB
A204852-003AB
A204852-004AB

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.

Product history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204852-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2020-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204852-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2020-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204852-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2020-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204852-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2020-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204852-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2020-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204852-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2020-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204852-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2020-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204852-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2020-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204852-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2020-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204852-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2020-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204852-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2020-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204852-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2020-02-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204852-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2020-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204852-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2020-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204852-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2020-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204852-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2020-02-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204852-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2020-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204852-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2020-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204852-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2020-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204852-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2020-02-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204852-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2020-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204852-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2020-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204852-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2020-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204852-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2020-02-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204852-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2020-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204852-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2020-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204852-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2020-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204852-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2020-02-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204852-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2020-02-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204852-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2020-02-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204852-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2020-02-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204852-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2020-02-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204852-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2020-02-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204852-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2020-02-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204852-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2020-02-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204852-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2020-02-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204852-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2020-02-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A204852-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2020-02-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A204852-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2020-02-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A204852-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2020-02-05d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204852-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204852-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204852-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204852-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204852-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204852-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204852-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204852-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204852-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204852-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204852-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204852-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204852-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204852-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204852-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204852-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204852-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204852-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204852-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204852-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204852-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204852-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204852-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204852-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204852-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204852-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204852-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204852-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204852-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204852-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204852-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204852-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204852-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204852-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204852-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204852-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204852-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204852-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204852-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204852-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAZODONE HYDROCHLORIDE150 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8fc1f03-cd9d-9fa9-e053-6294a90a8665Available 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
80425-0302-1Trazodone Hydrochloride30 in 1 BOTTLETABLET302
80425-0302-2Trazodone Hydrochloride60 in 1 BOTTLETABLET602
80425-0302-3Trazodone Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0302-1EA - Each80425-0302e59347b8-a31c-41a0-a19e-5292cfb355da12023-06-06
80425-0302-2EA - Each80425-0302ff54a817-29ff-4d14-8103-faa1111aca7012023-06-06
80425-0302-3EA - Each80425-030227e47cce-9408-4a39-9a80-5c7d1e61f0ba12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0302TRAZODONE HYDROCHLORIDE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f8fc1f03-cd9d-9fa9-e053-6294a90a8665.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEREMEDYREPACK INC.fec78f5d-2567-44d3-9f04-1a69133570192026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack34986e81-da05-46c1-8dd6-1dd7a8d1a44f2026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepackdfd2698d-b7a3-49e0-aa2f-1af0ca894b352026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf89ad429-0056-e4d6-e053-6294a90a7ab12026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack470a98a2-4e68-4c98-b3c8-e5eba4e55cdc2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepackfdd35113-5f51-49c5-a29c-ffdddd28ef382025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepackb57daea8-5a39-41c1-842e-b1d15115e36f2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack24b5eee4-4210-4b90-a695-11e6a58689882025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack7baa8eef-3a5c-43b3-a5fe-0c449aacda2e2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack4370fe5c-1c40-499b-abb5-bca0a39834c62025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepacka343910a-bf4c-4a41-b0ee-0e90e83558152025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack1514b3b0-7742-4247-b9fd-ea14849d3fdd2025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEREMEDYREPACK INC.b0a79ee7-3140-48cb-b734-244a4420e32c2025-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEAurolife Pharma LLC295e92a9-bcb0-4d53-ba62-e30020e9834b2025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC30ca6faa-316d-5754-e063-6394a90a7eff2025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf8fc1f03-cd9d-9fa9-e053-6294a90a86652024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
ndc (product): 80425-0302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856364traZODone HCl 150 MG Oral TabletPSNf8fc1f03-cd9d-9fa9-e053-6294a90a86652
856364trazodone hydrochloride 150 MG Oral TabletSCDf8fc1f03-cd9d-9fa9-e053-6294a90a86652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0302-18042503020130 TABLET in 1 BOTTLE (80425-0302-1) 30 tablet2023-04-10NoNoCurrent
80425-0302-28042503020260 TABLET in 1 BOTTLE (80425-0302-2) 60 tablet2023-04-10NoNoCurrent
80425-0302-38042503020390 TABLET in 1 BOTTLE (80425-0302-3) 90 tablet2023-04-10NoNoCurrent