FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
70934-153
Requested package NDC
70934-153-30
11-digit product format
709340153
Labeler code
70934
Product ID
70934-153_b9beb0fd-da78-6be9-e053-2995a90ac9a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA205253
Marketing category
ANDA
Marketing start
2018-08-15
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
2022-12-31
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 packagepackage70934-15370934-153-30DDiscontinued by firm2026-07-31

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-10a50c72e98297…
2026-08-01 22:54:322026-06A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-10a50c72e98297…
2026-08-01 22:54:322026-06A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-10a50c72e98297…
2026-08-01 22:54:322026-06A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205253-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205253-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A205253-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A205253-004AB1a50c72e98297…

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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-153-302023-02-08C16284748780-1ba0f9c33-1cfd-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
70934-153-902023-02-08C16284748780-1ba0f9c33-1cfd-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
70934-153-302023-01-30C16284748780-1ba0f9c33-1cfd-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
70934-153-902023-01-30C16284748780-1ba0f9c33-1cfd-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
70934-153-302021-01-31C16284748780-1ba0f9c33-1cfd-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
70934-153-902021-01-31C16284748780-1ba0f9c33-1cfd-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
70934-153-302021-01-29C16284748780-1ba0f9c33-1cfd-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
70934-153-902021-01-29C16284748780-1ba0f9c33-1cfd-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-153-307093401533030 TABLET in 1 BOTTLE, PLASTIC (70934-153-30) 30 tablet2018-08-150000-00-00NoNoCurrent