TRAZODONE HYDROCHLORIDE

Product NDC
61919-473
Requested package NDC
61919-473-30
11-digit product format
619190473
Labeler code
61919
Product ID
61919-473_ea4e7175-9459-6be8-e053-2a95a90a507c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAZODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA205253
Marketing category
ANDA
Marketing start
2019-08-19
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage61919-47361919-473-30IInactivated by FDA2026-08-03

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-10d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205253-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205253-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205253-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205253-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205253-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205253-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205253-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205253-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205253-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205253-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205253-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205253-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205253-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205253-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205253-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205253-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205253-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205253-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205253-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205253-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205253-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205253-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205253-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205253-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205253-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205253-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205253-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205253-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205253-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205253-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205253-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205253-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205253-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205253-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205253-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205253-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205253-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205253-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205253-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205253-004AB1d06236e962d9…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-473-302025-01-31C16284748780-11030e365-3aa2-111a-e063-dadaa90a10e2TRAZODONE HYDROCHLORIDE
61919-473-602025-01-30C16284748780-12cef2736-945f-d83d-e063-dadaa90ab31fTRAZODONE HYDROCHLORIDE
61919-473-902025-01-30C16284748780-12cef2736-9153-d83d-e063-dadaa90ab31fTRAZODONE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-473-30TRAZODONE HYDROCHLORIDE30 in 1 BOTTLETABLET303
61919-473-60TRAZODONE HYDROCHLORIDE60 in 1 BOTTLETABLET602
61919-473-90TRAZODONE HYDROCHLORIDE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-473-30EA - Each61919-473340e5a6a-a973-4aaa-b650-fdd23d26c83812018-04-19
61919-473-60EA - Each61919-4730ef9cb64-1052-49a0-b17b-5d76ffccaabf12019-09-05
61919-473-90EA - Each61919-473d62ad966-fc61-4aa2-972a-9f0b6d7e526112019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-473TRAZODONE HYDROCHLORIDE TABLET TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 1 package rows20190425_66da652a-72b4-c17f-e053-2a91aa0a8d69.zip
61919-473TRAZODONE HYDROCHLORIDE TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20221007_8fed1f86-49ab-4747-e053-2a95a90a42b8.zip
61919-473TRAZODONE HYDROCHLORIDE TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20221007_907d088e-b469-3c34-e053-2a95a90a257a.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 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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856364traZODone HCl 150 MG Oral TabletPSN66da652a-72b4-c17f-e053-2a91aa0a8d693
856377traZODone HCl 50 MG Oral TabletPSN66da652a-72b4-c17f-e053-2a91aa0a8d693
856364trazodone hydrochloride 150 MG Oral TabletSCD66da652a-72b4-c17f-e053-2a91aa0a8d693
856377trazodone hydrochloride 50 MG Oral TabletSCD66da652a-72b4-c17f-e053-2a91aa0a8d693
856364traZODone HCl 150 MG Oral TabletPSN8fed1f86-49ab-4747-e053-2a95a90a42b82
856364traZODone HCl 150 MG Oral TabletPSN907d088e-b469-3c34-e053-2a95a90a257a2
856364trazodone hydrochloride 150 MG Oral TabletSCD8fed1f86-49ab-4747-e053-2a95a90a42b82
856364trazodone hydrochloride 150 MG Oral TabletSCD907d088e-b469-3c34-e053-2a95a90a257a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-473-306191904733030 TABLET in 1 BOTTLE (61919-473-30) 30 tablet2018-03-070000-00-00NoNoCurrent