FDA.reportPublic FDA data

TRAZODONE HYDROCHLORIDE

Product NDC
13107-081
11-digit product format
131070081
Labeler code
13107
Product ID
13107-081_db4e6aff-149f-4f16-9512-e81e0c3e6900
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAZODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma LLC
Application
ANDA204852
Marketing category
ANDA
Marketing start
2015-09-15
Substance
TRAZODONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A204852-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2020-02-05
A204852-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2020-02-05
A204852-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2020-02-05
A204852-004TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2020-02-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A204852-001AB
A204852-002AB
A204852-003AB
A204852-004AB

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 22:54:322026-06A204852-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2020-02-05a50c72e98297…
2026-08-01 22:54:322026-06A204852-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2020-02-05a50c72e98297…
2026-08-01 22:54:322026-06A204852-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2020-02-05a50c72e98297…
2026-08-01 22:54:322026-06A204852-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2020-02-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204852-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204852-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A204852-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A204852-004AB1a50c72e98297…

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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEREMEDYREPACK INC.fec78f5d-2567-44d3-9f04-1a69133570192026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack34986e81-da05-46c1-8dd6-1dd7a8d1a44f2026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepackdfd2698d-b7a3-49e0-aa2f-1af0ca894b352026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf89ad429-0056-e4d6-e053-6294a90a7ab12026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack470a98a2-4e68-4c98-b3c8-e5eba4e55cdc2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepackfdd35113-5f51-49c5-a29c-ffdddd28ef382025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepackb57daea8-5a39-41c1-842e-b1d15115e36f2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack24b5eee4-4210-4b90-a695-11e6a58689882025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack7baa8eef-3a5c-43b3-a5fe-0c449aacda2e2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack4370fe5c-1c40-499b-abb5-bca0a39834c62025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepacka343910a-bf4c-4a41-b0ee-0e90e83558152025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack1514b3b0-7742-4247-b9fd-ea14849d3fdd2025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEREMEDYREPACK INC.b0a79ee7-3140-48cb-b734-244a4420e32c2025-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEAurolife Pharma LLC295e92a9-bcb0-4d53-ba62-e30020e9834b2025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
ndc (product): 13107-081
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC30ca6faa-316d-5754-e063-6394a90a7eff2025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf8fc1f03-cd9d-9fa9-e053-6294a90a86652024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204852
application number: ANDA204852

Additional Listing Data#

Finished product
Yes
Brand name base
TRAZODONE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAZODONE HYDROCHLORIDE150 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856364Internal RxNorm lookup
856369Internal 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
295e92a9-bcb0-4d53-ba62-e30020e9834bAvailable 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
13107-081-01TRAZODONE HYDROCHLORIDE100 in 1 BOTTLETABLET1009
13107-081-05TRAZODONE HYDROCHLORIDE500 in 1 BOTTLETABLET5009
13107-081-30TRAZODONE HYDROCHLORIDE30 in 1 BOTTLETABLET309
13107-081-99TRAZODONE HYDROCHLORIDE1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-081-01EA - Each13107-0810848ef39-1af9-4f00-843c-123754059aa812021-12-08
13107-081-05EA - Each13107-081a1a6bb46-1dbe-4211-bbce-ba4bb9e0f42812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-081TRAZODONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]9Current NDC, Legacy NDC, 4 package rows20250412_295e92a9-bcb0-4d53-ba62-e30020e9834b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856364traZODone HCl 150 MG Oral TabletPSNa343910a-bf4c-4a41-b0ee-0e90e8355815101
856364trazodone hydrochloride 150 MG Oral TabletSCDa343910a-bf4c-4a41-b0ee-0e90e8355815101
856364traZODone HCl 150 MG Oral TabletPSN24b5eee4-4210-4b90-a695-11e6a5868988100
856364trazodone hydrochloride 150 MG Oral TabletSCD24b5eee4-4210-4b90-a695-11e6a5868988100
856373traZODone HCl 100 MG Oral TabletPSN295e92a9-bcb0-4d53-ba62-e30020e9834b9
856364traZODone HCl 150 MG Oral TabletPSN295e92a9-bcb0-4d53-ba62-e30020e9834b9
856369traZODone HCl 300 MG Oral TabletPSN295e92a9-bcb0-4d53-ba62-e30020e9834b9
856377traZODone HCl 50 MG Oral TabletPSN295e92a9-bcb0-4d53-ba62-e30020e9834b9
856373trazodone hydrochloride 100 MG Oral TabletSCD295e92a9-bcb0-4d53-ba62-e30020e9834b9
856364trazodone hydrochloride 150 MG Oral TabletSCD295e92a9-bcb0-4d53-ba62-e30020e9834b9
856369trazodone hydrochloride 300 MG Oral TabletSCD295e92a9-bcb0-4d53-ba62-e30020e9834b9
856377trazodone hydrochloride 50 MG Oral TabletSCD295e92a9-bcb0-4d53-ba62-e30020e9834b9
856364traZODone HCl 150 MG Oral TabletPSNf8fc1f03-cd9d-9fa9-e053-6294a90a86652
856364trazodone hydrochloride 150 MG Oral TabletSCDf8fc1f03-cd9d-9fa9-e053-6294a90a86652
856364traZODone HCl 150 MG Oral TabletPSN34986e81-da05-46c1-8dd6-1dd7a8d1a44f1
856364trazodone hydrochloride 150 MG Oral TabletSCD34986e81-da05-46c1-8dd6-1dd7a8d1a44f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-081-0113107008101100 TABLET in 1 BOTTLE (13107-081-01) 100 tablet2015-09-150000-00-00NoNoCurrent
13107-081-0513107008105500 TABLET in 1 BOTTLE (13107-081-05) 500 tablet2015-09-150000-00-00NoNoCurrent
13107-081-201310700812020 TABLET in 1 BOTTLE (13107-081-20) 20 tablet2015-09-150000-00-00NoNoCurrent
13107-081-301310700813030 TABLET in 1 BOTTLE (13107-081-30) 30 tablet2015-09-15NoNoCurrent
13107-081-99131070081991000 TABLET in 1 BOTTLE (13107-081-99) 1000 tablet2015-09-150000-00-00NoNoCurrent