Home NDC 52817-395 Trazodone Hydrochloride
Product NDC 52817-395
11-digit product format 528170395
Labeler code 52817
Product ID 52817-395_203c92fc-3666-44b8-b89c-0b1acf94f137
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler TRUPHARMA LLC
Application ANDA072193
Marketing category ANDA
Marketing start 2026-09-03
Substance TRAZODONE HYDROCHLORIDE
Active strength 25 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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072193-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 A072193-002 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 25MG TABLET / ORAL RS 2026-09-01 A072193-003 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 75MG TABLET / ORAL RS 2026-09-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072193-001 AB
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 2 · 45 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A072193-002 TRAZODONE HYDROCHLORIDE 25MG TABLET / ORAL RS 2026-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A072193-003 TRAZODONE HYDROCHLORIDE 75MG TABLET / ORAL RS 2026-09-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 3bdfa0b2c4d7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Trazodone Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRAZODONE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6E8ZO8LRNM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2751852 Internal RxNorm lookup 2751854 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 52817-395-10 52817039510 100 TABLET, FILM COATED in 1 BOTTLE (52817-395-10) 2026-09-03 No No Current