Application 202180

Type
ANDA
Sponsor
TORRENT

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 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
A202180-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-27
A202180-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-27
A202180-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-27
A202180-004TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202180-001AB
A202180-002AB
A202180-003AB
A202180-004AB

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 06:07:402026-07A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202180-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2013-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202180-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2013-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202180-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2013-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202180-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2013-11-27d8e5a09893c0…

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 06:07:402026-07A202180-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202180-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202180-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202180-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202180-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202180-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202180-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202180-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202180-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202180-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202180-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202180-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202180-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202180-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202180-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202180-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202180-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202180-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202180-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202180-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202180-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202180-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202180-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202180-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202180-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202180-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202180-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202180-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202180-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202180-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202180-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202180-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202180-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202180-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202180-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202180-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202180-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202180-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202180-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202180-004AB1d8e5a09893c0…

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 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.1f74b23d-f2eb-4c18-a583-d608b77136942026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
ndc (product): 70518-3479
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.acd077db-e2b8-4d29-94c0-128439050c662026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
ndc (product): 70518-3426
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETorrent Pharmaceuticals Limited1510cf89-a2ec-4ed5-80cb-bae84f9ec0a72026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
ndc (product): 13668-330
ndc (product): 13668-332
ndc (product): 13668-333
ndc (product): 13668-331
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf98b1e8f-9c66-3e9c-e053-6294a90ab0572025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.f7e6a78e-7ac3-35b9-e053-6294a90aabd02025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepackadc7427e-3553-4805-b063-eeda840490292025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fc9b90d1-7da5-efc1-e053-6294a90a02232025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC29ac7183-e574-506e-e063-6394a90a77c92024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEA-S Medication Solutionsbe0dc037-d30a-4f07-ab7c-1695637b37402024-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepacka71063f9-cdc6-46bc-9eb4-626f288e46d92024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
ndc (product): 71335-2084
Trazodone HCLTRAZODONE HCLDirect_Rx1fd0fc6d-5b1c-9f6a-e063-6394a90a3b7c2024-08-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEMedsource Pharmaceuticals138fef7b-db83-88c4-e063-6394a90ab0ac2024-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LP3c8c3d2b-9108-40fa-90d9-6ed545cf65492023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LP2a1d0989-6ed5-4a2f-bd03-73d61eb402322022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202180
application number: ANDA202180
ndc (product): 71205-505

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
13668-330Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-330Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-330Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-330Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-330Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-331Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-331Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-331Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-331Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-331Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-332Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-332Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-332Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-332Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-332Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-333Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-333Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-333Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-333Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-333Trazodone HydrochlorideTrazodone HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
53002-2132Trazodone HydrochlorideTrazodone HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-4105Trazodone HydrochlorideTrazodone HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
55700-957Trazodone HydrochlorideTrazodone HydrochlorideQuality Care Products, LLCANDACurrent
55700-957Trazodone HydrochlorideTrazodone HydrochlorideQuality Care Products, LLCANDACurrent
55700-957Trazodone HydrochlorideTrazodone HydrochlorideQuality Care Products, LLCANDACurrent
70518-3426Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3479Trazodone HydrochlorideTrazodone HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-817Trazodone HydrochlorideTrazodone HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-505Trazodone HydrochlorideTrazodone HydrochlorideProficient Rx LPANDACurrent
71205-505Trazodone HydrochlorideTrazodone HydrochlorideProficient Rx LPANDACurrent
71335-2084Trazodone HydrochlorideTrazodone HydrochlorideBryant Ranch PrepackANDACurrent