Trazodone Hydrochloride

Product NDC
50090-6603
11-digit product format
500906603
Labeler code
50090
Product ID
50090-6603_30db7ddc-f345-457d-a04f-1258502e147e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA205253
Marketing category
ANDA
Marketing start
2017-12-11
Marketing end
2028-12-31
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 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 42.

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.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-10caaa826d4ba7…
2026-08-18 06:07:402026-07A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-10caaa826d4ba7…
2026-08-18 06:07:402026-07A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-10caaa826d4ba7…
2026-08-18 06:07:402026-07A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-10d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A205253-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205253-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205253-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205253-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205253-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205253-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205253-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205253-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205253-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205253-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205253-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205253-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205253-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205253-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205253-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205253-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205253-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205253-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205253-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205253-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205253-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205253-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205253-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205253-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205253-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205253-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205253-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205253-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205253-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205253-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205253-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205253-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205253-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205253-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205253-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205253-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205253-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205253-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205253-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205253-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAZODONE HYDROCHLORIDE50 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
007f38e0-653b-43e4-a1c1-b59997b2762aAvailable 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
50090-6603-0Trazodone Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6603-0EA - Each50090-66033eb1a563-a529-452e-a2be-ffcf3032d10d12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6603TRAZODONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20230831_007f38e0-653b-43e4-a1c1-b59997b2762a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAmerican Health Packagingf715085a-be56-497e-ad92-9fec3aba70b52026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENuCare Pharmceuticals,Inc.81a5b557-06f6-2470-e053-2991aa0a64fd2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.a31d59ed-5949-4f85-8b73-3bfd7f72d5b82026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
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
ndc (product): 50090-6603
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 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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSN007f38e0-653b-43e4-a1c1-b59997b2762a1
856377trazodone hydrochloride 50 MG Oral TabletSCD007f38e0-653b-43e4-a1c1-b59997b2762a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6603-05009066030090 TABLET in 1 BOTTLE (50090-6603-0) 90 tablet2023-08-222028-12-31NoNoHistorical