FDA.reportPublic FDA data

Application 206923

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDETABLET;ORAL50MGNoNo
002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDETABLET;ORAL100MGNoNo
003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDETABLET;ORAL150MGNoNo
004TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDETABLET;ORAL300MGNoNo

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
A206923-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-08
A206923-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-08
A206923-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-08
A206923-004TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206923-001AB
A206923-002AB
A206923-003AB
A206923-004AB

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 22:54:322026-06A206923-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-08a50c72e98297…
2026-08-01 22:54:322026-06A206923-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-08a50c72e98297…
2026-08-01 22:54:322026-06A206923-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-08a50c72e98297…
2026-08-01 22:54:322026-06A206923-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206923-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206923-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A206923-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A206923-004AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepack5605e909-dc75-4578-94c6-41bb96ba3e2a2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206923
application number: ANDA206923
ndc (product): 71335-1483
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepack78c3188c-d42f-4d3d-aa42-3c146dfe08ee2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206923
application number: ANDA206923
ndc (product): 71335-1575
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAccord Healthcare, Inc.ed3039d8-3d27-4b71-a4b0-812943c9457f2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206923
application number: ANDA206923
ndc (product): 16729-301
ndc (product): 16729-299
ndc (product): 16729-302
ndc (product): 16729-300
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LPa90caa68-b28e-425f-b77c-7b566ac17dc22022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206923
application number: ANDA206923
ndc (product): 71205-630

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-299Trazodone HydrochlorideTrazodone HydrochlorideAccord Healthcare, Inc.ANDACurrent
16729-299Trazodone HydrochlorideTrazodone HydrochlorideAccord Healthcare, Inc.ANDACurrent
16729-300Trazodone HydrochlorideTrazodone HydrochlorideAccord Healthcare, Inc.ANDACurrent
16729-300Trazodone HydrochlorideTrazodone HydrochlorideAccord Healthcare, Inc.ANDACurrent
16729-301Trazodone HydrochlorideTrazodone HydrochlorideAccord Healthcare, Inc.ANDACurrent
16729-301Trazodone HydrochlorideTrazodone HydrochlorideAccord Healthcare, Inc.ANDACurrent
16729-302Trazodone HydrochlorideTrazodone HydrochlorideAccord Healthcare, Inc.ANDACurrent
16729-302Trazodone HydrochlorideTrazodone HydrochlorideAccord Healthcare, Inc.ANDACurrent
50090-6121Trazodone HydrochlorideTrazodone HydrochlorideA-S Medication SolutionsANDACurrent
55700-739Trazodone HydrochlorideTrazodone HydrochlorideQuality Care Products, LLCANDACurrent
55700-739Trazodone HydrochlorideTrazodone HydrochlorideQuality Care Products, LLCANDACurrent
55700-739Trazodone HydrochlorideTrazodone HydrochlorideQuality Care Products, LLCANDACurrent
55700-782Trazodone HydrochlorideTrazodone HydrochlorideQuality Care Products, LLCANDACurrent
55700-782Trazodone HydrochlorideTrazodone HydrochlorideQuality Care Products, LLCANDACurrent
55700-844Trazodone HydrochlorideTrazodone HydrochlorideQuality Care Products, LLCANDACurrent
55700-844Trazodone HydrochlorideTrazodone HydrochlorideQuality Care Products, LLCANDACurrent
55700-844Trazodone HydrochlorideTrazodone HydrochlorideQuality Care Products, LLCANDACurrent
67296-1411Trazodone HydrochlorideTrazodone HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-5187Trazodone HydrochlorideTrazodone HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5187Trazodone HydrochlorideTrazodone HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-3082Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-370Trazodone HydrochlorideTrazodone HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-370Trazodone HydrochlorideTrazodone HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-370Trazodone HydrochlorideTrazodone HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-620Trazodone HydrochlorideTrazodone HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-630Trazodone HydrochlorideTrazodone HydrochlorideProficient Rx LPANDACurrent
71205-630Trazodone HydrochlorideTrazodone HydrochlorideProficient Rx LPANDACurrent
71335-1483Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1483Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1575Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1575Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent