FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
70771-1129
11-digit product format
707711129
Labeler code
70771
Product ID
70771-1129_0b9d3b91-26ed-477b-a88e-2d6a76fedabf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA205253
Marketing category
ANDA
Marketing start
2017-12-11
Marketing end
2028-12-31
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
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
ndc (product): 70771-1129
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
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

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 · 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
43d4be17-5fae-4326-a5c4-9e25e2db6a43Available 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
70771-1129-0Trazodone Hydrochloride1000 in 1 BOTTLETABLET10008
70771-1129-1Trazodone Hydrochloride100 in 1 BOTTLETABLET1008
70771-1129-2Trazodone Hydrochloride10 in 1 BLISTER PACKTABLET108
70771-1129-3Trazodone Hydrochloride30 in 1 BOTTLETABLET308
70771-1129-4Trazodone Hydrochloride10 in 1 CARTONTABLET108
70771-1129-5Trazodone Hydrochloride500 in 1 BOTTLETABLET5008
70771-1129-9Trazodone Hydrochloride90 in 1 BOTTLETABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1129TRAZODONE HYDROCHLORIDE TABLET [ZYDUS LIFESCIENCES LIMITED]7Current NDC, Legacy NDC, 7 package rows20250503_43d4be17-5fae-4326-a5c4-9e25e2db6a43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN43d4be17-5fae-4326-a5c4-9e25e2db6a438
856364traZODone HCl 150 MG Oral TabletPSN43d4be17-5fae-4326-a5c4-9e25e2db6a438
856369traZODone HCl 300 MG Oral TabletPSN43d4be17-5fae-4326-a5c4-9e25e2db6a438
856377traZODone HCl 50 MG Oral TabletPSN43d4be17-5fae-4326-a5c4-9e25e2db6a438
856373trazodone hydrochloride 100 MG Oral TabletSCD43d4be17-5fae-4326-a5c4-9e25e2db6a438
856364trazodone hydrochloride 150 MG Oral TabletSCD43d4be17-5fae-4326-a5c4-9e25e2db6a438
856369trazodone hydrochloride 300 MG Oral TabletSCD43d4be17-5fae-4326-a5c4-9e25e2db6a438
856377trazodone hydrochloride 50 MG Oral TabletSCD43d4be17-5fae-4326-a5c4-9e25e2db6a438

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1129-0707711129001000 TABLET in 1 BOTTLE (70771-1129-0) 1000 tablet2017-12-112028-12-31NoNoCurrent
70771-1129-170771112901100 TABLET in 1 BOTTLE (70771-1129-1) 100 tablet2017-12-112028-12-31NoNoCurrent
70771-1129-27077111290210 in 1 BLISTER PACKHistorical
70771-1129-37077111290330 TABLET in 1 BOTTLE (70771-1129-3) 30 tablet2017-12-112028-12-31NoNoCurrent
70771-1129-47077111290410 BLISTER PACK in 1 CARTON (70771-1129-4) / 10 TABLET in 1 BLISTER PACK (70771-1129-2) 10 blister pack2017-12-112028-12-31NoNoCurrent
70771-1129-570771112905500 TABLET in 1 BOTTLE (70771-1129-5) 500 tablet2017-12-112028-12-31NoNoCurrent
70771-1129-97077111290990 TABLET in 1 BOTTLE (70771-1129-9) 90 tablet2017-12-112028-12-31NoNoCurrent