Trazodone Hydrochloride

Product NDC
70518-3426
11-digit product format
705183426
Labeler code
70518
Product ID
70518-3426_4f081573-6cdc-8261-e063-6294a90a56bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202180
Marketing category
ANDA
Marketing start
2022-05-25
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-342670518-3426-0DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-27d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202180-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202180-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202180-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202180-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride
Listing expiration
2027-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
acd077db-e2b8-4d29-94c0-128439050c66Available 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
70518-3426-0Trazodone Hydrochloride30 in 1 BLISTER PACKTABLET307
70518-3426-1Trazodone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3426TRAZODONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 2 package rows20241116_acd077db-e2b8-4d29-94c0-128439050c66.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ndc (product): 70518-3426
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
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
856373traZODone HCl 100 MG Oral TabletPSNacd077db-e2b8-4d29-94c0-128439050c667
856373trazodone hydrochloride 100 MG Oral TabletSCDacd077db-e2b8-4d29-94c0-128439050c667

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3426-07051834260030 TABLET in 1 BLISTER PACK (70518-3426-0) 30 tablet2022-05-250000-00-00NoNoCurrent
70518-3426-17051834260190 TABLET in 1 BOTTLE, PLASTIC (70518-3426-1) 90 tablet2024-05-29NoNoCurrent