Trazodone Hydrochloride

Product NDC
53002-2132
Requested package NDC
53002-2132-0
11-digit product format
530022132
Labeler code
53002
Product ID
53002-2132_e830df6f-5218-4781-87ab-6303bfa5c513
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA202180
Marketing category
ANDA
Marketing start
2013-11-27
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53002-213253002-2132-0IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 3 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-213253002-2132-0UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-213253002-2132-0UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-213253002-2132-0UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…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
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 · 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 UTC2026-02A202180-001TRAZODONE 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…
2024-10-29 15:01 UTC2024-10A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-27d06236e962d9…

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 UTC2026-02A202180-001AB1011fe1cb6892…
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…
2024-10-29 15:01 UTC2024-10A202180-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202180-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202180-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202180-004AB1d06236e962d9…

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 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.1f74b23d-f2eb-4c18-a583-d608b77136942026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.acd077db-e2b8-4d29-94c0-128439050c662026-04-09Boxed 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
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 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2132-0Trazodone Hydrochloride100 in 1 BOTTLETABLET1001
53002-2132-3Trazodone Hydrochloride30 in 1 BOTTLETABLET301
53002-2132-6Trazodone Hydrochloride60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2132TRAZODONE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20220331_5bb98507-6c62-4892-b514-782209e680d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSN5bb98507-6c62-4892-b514-782209e680d11
856377trazodone hydrochloride 50 MG Oral TabletSCD5bb98507-6c62-4892-b514-782209e680d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2132-053002213200100 TABLET in 1 BOTTLE (53002-2132-0) 100 tablet2021-01-010000-00-00NoNoCurrent