FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
50111-561
Requested package NDC
50111-561-88
11-digit product format
501110561
Labeler code
50111
Product ID
50111-561_3313a8d0-eb39-47a4-b476-0973aad30e02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA071524
Marketing category
ANDA
Marketing start
2020-10-08
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
unfinished packagepackage50111-56150111-561-88UNFINISHEDActive or certified unfinished drug listing2026-07-31

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
A071524-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071524-001AB

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 22:54:322026-06A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A071524-001AB1a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsdf17cec9-ad5e-4e57-8572-c927c9b955e22026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.7bba99e5-4096-4fcb-8591-dc4a9bfe975e2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAvKAREb3723265-7455-c25c-e053-2a95a90a379b2026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b617348c-cb19-45df-b313-4ea6af6f1dda2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENorthwind Health Company, LLCe07d7ee3-776d-1fa3-e053-2a95a90a70192026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd42fd0c8-3673-4f18-a6c0-cd276bbf9fef2025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5ab590d8-225f-43f4-bb68-1f2c86f9a8862025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.4006d439-e2de-4590-82e9-fc9d56e3ec1b2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
ndc (product): 50111-561
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LP203881a3-37d0-41dd-86c5-1e53fb7843262023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride
Listing expiration
2026-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856364Internal RxNorm lookup
856373Internal RxNorm lookup
856377Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4006d439-e2de-4590-82e9-fc9d56e3ec1bAvailable 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
50111-561-01Trazodone Hydrochloride100 in 1 BOTTLETABLET10030
50111-561-02Trazodone Hydrochloride500 in 1 BOTTLETABLET50030
50111-561-03Trazodone Hydrochloride1000 in 1 BOTTLETABLET100030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50111-561-01EA - Each50111-561977fa415-e7ff-4952-97b3-88cddc4f3c0912021-01-08
50111-561-02EA - Each50111-561f556bdc9-6277-4784-9987-275a0353990312021-01-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]9
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]9
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50111-561TRAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]28Current NDC, Legacy NDC, 3 package rows20230210_4006d439-e2de-4590-82e9-fc9d56e3ec1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNb617348c-cb19-45df-b313-4ea6af6f1dda32
856373trazodone hydrochloride 100 MG Oral TabletSCDb617348c-cb19-45df-b313-4ea6af6f1dda32
856373traZODone HCl 100 MG Oral TabletPSNdf17cec9-ad5e-4e57-8572-c927c9b955e230
856373traZODone HCl 100 MG Oral TabletPSN4006d439-e2de-4590-82e9-fc9d56e3ec1b30
856364traZODone HCl 150 MG Oral TabletPSN4006d439-e2de-4590-82e9-fc9d56e3ec1b30
856377traZODone HCl 50 MG Oral TabletPSN4006d439-e2de-4590-82e9-fc9d56e3ec1b30
856373trazodone hydrochloride 100 MG Oral TabletSCD4006d439-e2de-4590-82e9-fc9d56e3ec1b30
856373trazodone hydrochloride 100 MG Oral TabletSCDdf17cec9-ad5e-4e57-8572-c927c9b955e230
856364trazodone hydrochloride 150 MG Oral TabletSCD4006d439-e2de-4590-82e9-fc9d56e3ec1b30
856377trazodone hydrochloride 50 MG Oral TabletSCD4006d439-e2de-4590-82e9-fc9d56e3ec1b30
856373traZODone HCl 100 MG Oral TabletPSN7bba99e5-4096-4fcb-8591-dc4a9bfe975e13
856373trazodone hydrochloride 100 MG Oral TabletSCD7bba99e5-4096-4fcb-8591-dc4a9bfe975e13
856373traZODone HCl 100 MG Oral TabletPSNb3723265-7455-c25c-e053-2a95a90a379b5
856377traZODone HCl 50 MG Oral TabletPSNb3723265-7455-c25c-e053-2a95a90a379b5
856373trazodone hydrochloride 100 MG Oral TabletSCDb3723265-7455-c25c-e053-2a95a90a379b5
856377trazodone hydrochloride 50 MG Oral TabletSCDb3723265-7455-c25c-e053-2a95a90a379b5
856373traZODone HCl 100 MG Oral TabletPSNd42fd0c8-3673-4f18-a6c0-cd276bbf9fef4
856377traZODone HCl 50 MG Oral TabletPSNd42fd0c8-3673-4f18-a6c0-cd276bbf9fef4
856373trazodone hydrochloride 100 MG Oral TabletSCDd42fd0c8-3673-4f18-a6c0-cd276bbf9fef4
856377trazodone hydrochloride 50 MG Oral TabletSCDd42fd0c8-3673-4f18-a6c0-cd276bbf9fef4
856373traZODone HCl 100 MG Oral TabletPSNe07d7ee3-776d-1fa3-e053-2a95a90a70193
856373trazodone hydrochloride 100 MG Oral TabletSCDe07d7ee3-776d-1fa3-e053-2a95a90a70193
856373traZODone HCl 100 MG Oral TabletPSN6ca1bb42-c1f5-4219-8a68-a59f576639172
856373traZODone HCl 100 MG Oral TabletPSN203881a3-37d0-41dd-86c5-1e53fb7843262
856373trazodone hydrochloride 100 MG Oral TabletSCD6ca1bb42-c1f5-4219-8a68-a59f576639172
856373trazodone hydrochloride 100 MG Oral TabletSCD203881a3-37d0-41dd-86c5-1e53fb7843262

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
50111-561-885011105618835000 TABLET in 1 CONTAINER (50111-561-88)35000 tablet20-JUN-25Current