Trazodone Hydrochloride

Product NDC
55700-855
11-digit product format
557000855
Labeler code
55700
Product ID
55700-855_f392f8d4-600d-4c98-b60b-47362fd0721f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA205253
Marketing category
ANDA
Marketing start
2020-04-03
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-855DDiscontinued by firm2026-10-05
excluded packagepackage55700-85555700-855-30DDiscontinued by firm2026-10-05
excluded packagepackage55700-85555700-855-60DDiscontinued by firm2026-10-05
excluded packagepackage55700-85555700-855-90DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0555700-855-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0555700-855-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2655700-855-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3155700-855-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2855700-855-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2155700-855-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1055700-855-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3155700-855-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2055700-855-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1055700-855-900efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A205253-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-1084e616aacf4f…
2026-09-14 22:38:342026-08A205253-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-1084e616aacf4f…
2026-09-14 22:38:342026-08A205253-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-1084e616aacf4f…
2026-09-14 22:38:342026-08A205253-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-10-1084e616aacf4f…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A205253-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A205253-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A205253-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A205253-004AB184e616aacf4f…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-855-30EA - Each55700-8558ba92257-ecf3-44a9-a80c-b18a669c0ca912020-05-08
55700-855-60EA - Each55700-8557684c304-1109-45ab-b95f-3fb217254a2b12020-05-08
55700-855-90EA - Each55700-855aba86714-1f33-4733-9c24-0626a5f5ae6212021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-855TRAZODONE HYDROCHLORIDE TABLET [QUALITY CARE PRODUCTS, LLC]7Legacy NDC20241220_22f6618e-82ae-4474-a472-d966222d8ffb.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 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPreferred Pharmaceuticals Inc.9962589c-ee1f-4d5e-bd49-b7807bb60ace2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEMajor Pharmaceuticals8eb85c26-a6cb-4a10-a990-ccc0b20aff082025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDECardinal Health 107, LLC9265f4f6-df24-4495-9dbf-e3fcfa4c864d2025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepack42ecd35c-4300-4cd3-942a-f3efb872fa992025-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepack65ef34fb-8fe4-4e9d-9068-98702515ffeb2025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC2d3f1d0b-3686-f4d7-e063-6394a90a1a762025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
TRAZODONE HCLTRAZODONE HCLAdvanced Rx Pharmacy of Tennessee, LLCd27e4473-6f62-ddfe-e053-2a95a90a9a2c2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepack9df17765-5d41-4e26-98de-8506581145342024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.85bb3f78-5cf2-1319-e053-2991aa0ade752024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.6adb446d-cd2f-3d6b-e053-2991aa0a21142024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LP88ac1a9d-8483-4b29-9fe6-2e60e51f30052024-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEMedsource Pharmaceuticals12f1737b-c021-d0f2-e063-6294a90a6f292024-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAsclemed USA, Inc.04a676ee-358e-484d-9de4-a9a88d908ba82024-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEA-S Medication Solutions3df90104-ef2c-4a82-b007-9843c43969ae2023-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEA-S Medication Solutionsac678c51-b1d3-4d6b-9599-7ef565b469d22023-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205253
application number: ANDA205253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-855-305570008553030 TABLET in 1 BOTTLE (55700-855-30) 30 tablet2020-04-030000-00-00NoNoCurrent
55700-855-605570008556060 TABLET in 1 BOTTLE (55700-855-60) 60 tablet2020-04-030000-00-00NoNoCurrent
55700-855-905570008559090 TABLET in 1 BOTTLE (55700-855-90) 90 tablet2021-09-100000-00-00NoNoCurrent