FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
50090-4283
11-digit product format
500904283
Labeler code
50090
Product ID
50090-4283_80b1089d-f033-4c8a-81cf-a4e44e3309bc
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
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
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
ndc (product): 50090-4283
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

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride
Listing expiration
2027-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
353e66cc-98ca-4500-97e7-00f23f122349Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4283-02023-02-07C16284748780-1f386c64a-22e2-0266-e053-dadaa90a7c1aThese 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
50090-4283-22023-02-07C16284748780-1f386c64a-22e2-0266-e053-dadaa90a7c1aThese 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
50090-4283-32023-02-07C16284748780-1f386c64a-22e2-0266-e053-dadaa90a7c1aThese 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
50090-4283-02023-01-30C16284748780-1f386c64a-22e2-0266-e053-dadaa90a7c1aThese 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
50090-4283-22023-01-30C16284748780-1f386c64a-22e2-0266-e053-dadaa90a7c1aThese 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
50090-4283-32023-01-30C16284748780-1f386c64a-22e2-0266-e053-dadaa90a7c1aThese 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4283-0Trazodone Hydrochloride30 in 1 BOTTLETABLET3011
50090-4283-2Trazodone Hydrochloride60 in 1 BOTTLETABLET6011
50090-4283-3Trazodone Hydrochloride90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4283-0EA - Each50090-42830c318011-2a92-4c15-9fcd-966468e824a512022-04-06
50090-4283-2EA - Each50090-4283c19b3ff3-a3e8-4937-aee0-f28834c333e012022-04-06
50090-4283-3EA - Each50090-4283a22152b4-7fb1-40c5-a09d-93d00e58a95f12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4283TRAZODONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 3 package rows20231229_353e66cc-98ca-4500-97e7-00f23f122349.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN353e66cc-98ca-4500-97e7-00f23f12234911
856373trazodone hydrochloride 100 MG Oral TabletSCD353e66cc-98ca-4500-97e7-00f23f12234911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4283-05009042830030 TABLET in 1 BOTTLE (50090-4283-0) 30 tablet2019-04-260000-00-00NoNoCurrent
50090-4283-25009042830260 TABLET in 1 BOTTLE (50090-4283-2) 60 tablet2019-04-260000-00-00NoNoCurrent
50090-4283-35009042830390 TABLET in 1 BOTTLE (50090-4283-3) 90 tablet2019-04-260000-00-00NoNoCurrent