Trazodone Hydrochloride

Product NDC
80425-0462
Requested package NDC
80425-0462-1
11-digit product format
804250462
Labeler code
80425
Product ID
80425-0462_29ac720e-f2ab-f45b-e063-6394a90a165e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA202180
Marketing category
ANDA
Marketing start
2024-12-19
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 43.

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
A202180-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-27
A202180-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-27
A202180-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-27
A202180-004TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202180-001AB
A202180-002AB
A202180-003AB
A202180-004AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-2784e616aacf4f…
2026-09-14 22:38:342026-08A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-2784e616aacf4f…
2026-09-14 22:38:342026-08A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-2784e616aacf4f…
2026-09-14 22:38:342026-08A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-2784e616aacf4f…
2026-08-18 06:07:402026-07A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-275bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202180-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202180-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A202180-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A202180-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A202180-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202180-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202180-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202180-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202180-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202180-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202180-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202180-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202180-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202180-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202180-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202180-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202180-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202180-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202180-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202180-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202180-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202180-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202180-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202180-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202180-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202180-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202180-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202180-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202180-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202180-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202180-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202180-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202180-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202180-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202180-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202180-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202180-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202180-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202180-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202180-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
29ac7183-e574-506e-e063-6394a90a77c9Available 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
80425-0462-1Trazodone Hydrochloride30 in 1 BOTTLETABLET301
80425-0462-2Trazodone Hydrochloride60 in 1 BOTTLETABLET601
80425-0462-3Trazodone Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0462-1EA - Each80425-0462235a9560-fc5c-457f-b41c-24bb59606b1712025-02-10
80425-0462-2EA - Each80425-0462074534e8-0302-47f2-b0e3-f279f81d95fa12025-02-10
80425-0462-3EA - Each80425-0462a2dca7e8-c246-4720-ab8b-2d94cb6b992012025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0462TRAZODONE HYDROCHLORIDE TABLET [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20241222_29ac7183-e574-506e-e063-6394a90a77c9.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.596c3f00-1504-eaed-e063-6294a90a08bb2026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.1f74b23d-f2eb-4c18-a583-d608b77136942026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.acd077db-e2b8-4d29-94c0-128439050c662026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETorrent Pharmaceuticals Limited1510cf89-a2ec-4ed5-80cb-bae84f9ec0a72026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf98b1e8f-9c66-3e9c-e053-6294a90ab0572025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.f7e6a78e-7ac3-35b9-e053-6294a90aabd02025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepackadc7427e-3553-4805-b063-eeda840490292025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fc9b90d1-7da5-efc1-e053-6294a90a02232025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC29ac7183-e574-506e-e063-6394a90a77c92024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
ndc (package): 80425-0462-1
ndc (product): 80425-0462
ndc11 (package): 80425046201
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEA-S Medication Solutionsbe0dc037-d30a-4f07-ab7c-1695637b37402024-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepacka71063f9-cdc6-46bc-9eb4-626f288e46d92024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HCLTRAZODONE HCLDirect_Rx1fd0fc6d-5b1c-9f6a-e063-6394a90a3b7c2024-08-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEMedsource Pharmaceuticals138fef7b-db83-88c4-e063-6394a90ab0ac2024-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LP3c8c3d2b-9108-40fa-90d9-6ed545cf65492023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LP2a1d0989-6ed5-4a2f-bd03-73d61eb402322022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856364traZODone HCl 150 MG Oral TabletPSN29ac7183-e574-506e-e063-6394a90a77c91
856364trazodone hydrochloride 150 MG Oral TabletSCD29ac7183-e574-506e-e063-6394a90a77c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0462-18042504620130 TABLET in 1 BOTTLE (80425-0462-1) 30 tablet2024-12-19NoNoCurrent