Trazodone Hydrochloride

Product NDC
50111-441
Requested package NDC
50111-441-02
11-digit product format
501110441
Labeler code
50111
Product ID
50111-441_2f6356fb-56c5-4b3a-92ec-c881765bfc01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA071525
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
2021-10-31
Substance
TRAZODONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage50111-44150111-441-02DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071525-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071525-001AB

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 22:54:322026-06A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A071525-001AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs310c4b81-d2cf-4014-873d-e71d036105de2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071525
application number: ANDA071525
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAvKAREa382ac4d-9ab9-796a-e053-2a95a90a2c262026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071525
application number: ANDA071525
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9b022ae9-dd52-43ae-804b-ddf8e7cfd5302025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071525
application number: ANDA071525
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.4006d439-e2de-4590-82e9-fc9d56e3ec1b2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071525
application number: ANDA071525

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50111-441-01EA - Each50111-44140fe84ed-e2e6-48e1-9039-fc77ad1fa22d12012-07-24
50111-441-02EA - Each50111-44103d7641f-25c2-44a3-a439-458471d6e8e812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3382
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3382
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAZODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3382
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3382
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3382
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3382
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3382
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]11
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]11
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAZODONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]11
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JTRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
Starch, CornINACTIVE INGREDIENTO8232NY3SJTRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE (TRAZODONE) TABLET [REBEL DISTRIBUTORS CORP.]2
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE (TRAZODONE) TABLET [REBEL DISTRIBUTORS CORP.]2
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAZODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]1
Trazodone HydrochlorideACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]1
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]1
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TrazodoneACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]1
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAZODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856364traZODone HCl 150 MG Oral TabletPSN6963a2cc-1c0b-4795-acb4-024488d517ce9
856377traZODone HCl 50 MG Oral TabletPSN6963a2cc-1c0b-4795-acb4-024488d517ce9
856364trazodone hydrochloride 150 MG Oral TabletSCD6963a2cc-1c0b-4795-acb4-024488d517ce9
856377trazodone hydrochloride 50 MG Oral TabletSCD6963a2cc-1c0b-4795-acb4-024488d517ce9
856364traZODone HCl 150 MG Oral TabletPSN29c443fc-8ef6-4778-8d6a-ad14181ef8de7
856364trazodone hydrochloride 150 MG Oral TabletSCD29c443fc-8ef6-4778-8d6a-ad14181ef8de7
856364traZODone HCl 150 MG Oral TabletPSNe1ae415e-daf6-4b23-a545-e71a8acba1f63
856364trazodone hydrochloride 150 MG Oral TabletSCDe1ae415e-daf6-4b23-a545-e71a8acba1f63
856373traZODone HCl 100 MG Oral TabletPSNdf555ed8-2d8c-45fd-8bf1-aa72c49090c02
856373traZODone HCl 100 MG Oral TabletPSN6f43cdc2-4f8e-4a5f-976a-d3aaac65593d2
856364traZODone HCl 150 MG Oral TabletPSN6f43cdc2-4f8e-4a5f-976a-d3aaac65593d2
856364traZODone HCl 150 MG Oral TabletPSNdf555ed8-2d8c-45fd-8bf1-aa72c49090c02
856377traZODone HCl 50 MG Oral TabletPSN6f43cdc2-4f8e-4a5f-976a-d3aaac65593d2
856377traZODone HCl 50 MG Oral TabletPSNdf555ed8-2d8c-45fd-8bf1-aa72c49090c02
856373trazodone hydrochloride 100 MG Oral TabletSCD6f43cdc2-4f8e-4a5f-976a-d3aaac65593d2
856373trazodone hydrochloride 100 MG Oral TabletSCDdf555ed8-2d8c-45fd-8bf1-aa72c49090c02
856364trazodone hydrochloride 150 MG Oral TabletSCDdf555ed8-2d8c-45fd-8bf1-aa72c49090c02
856364trazodone hydrochloride 150 MG Oral TabletSCD6f43cdc2-4f8e-4a5f-976a-d3aaac65593d2
856377trazodone hydrochloride 50 MG Oral TabletSCDdf555ed8-2d8c-45fd-8bf1-aa72c49090c02
856377trazodone hydrochloride 50 MG Oral TabletSCD6f43cdc2-4f8e-4a5f-976a-d3aaac65593d2
856373traZODone HCl 100 MG Oral TabletPSN3f8d7e17-b580-4340-bd8f-e76f8ba004221
856373traZODone HCl 100 MG Oral TabletPSN10124262-e443-49a5-a1cc-8cc34c74d9531
856364traZODone HCl 150 MG Oral TabletPSNaf82c9b0-1c3a-407a-aa5d-f15b9217b5c61
856364traZODone HCl 150 MG Oral TabletPSN3f8d7e17-b580-4340-bd8f-e76f8ba004221
856364traZODone HCl 150 MG Oral TabletPSN10124262-e443-49a5-a1cc-8cc34c74d9531
856377traZODone HCl 50 MG Oral TabletPSN3f8d7e17-b580-4340-bd8f-e76f8ba004221
856377traZODone HCl 50 MG Oral TabletPSN10124262-e443-49a5-a1cc-8cc34c74d9531
856373trazodone hydrochloride 100 MG Oral TabletSCD10124262-e443-49a5-a1cc-8cc34c74d9531
856373trazodone hydrochloride 100 MG Oral TabletSCD3f8d7e17-b580-4340-bd8f-e76f8ba004221
856364trazodone hydrochloride 150 MG Oral TabletSCDaf82c9b0-1c3a-407a-aa5d-f15b9217b5c61
856364trazodone hydrochloride 150 MG Oral TabletSCD10124262-e443-49a5-a1cc-8cc34c74d9531
856364trazodone hydrochloride 150 MG Oral TabletSCD3f8d7e17-b580-4340-bd8f-e76f8ba004221
856377trazodone hydrochloride 50 MG Oral TabletSCD10124262-e443-49a5-a1cc-8cc34c74d9531
856377trazodone hydrochloride 50 MG Oral TabletSCD3f8d7e17-b580-4340-bd8f-e76f8ba004221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50111-441-0250111044102500 TABLET in 1 BOTTLE (50111-441-02) 500 tablet1990-09-302021-10-31NoNoCurrent