Home NDC 64980-673 TRAZODONE HYDROCHLORIDE
Product NDC 64980-673
11-digit product format 649800673
Labeler code 64980
Product ID 64980-673_ab9a16ff-7bca-4445-b6e5-5122e097995c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name trazodone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA217740
Marketing category ANDA
Marketing start 2025-01-29
Substance TRAZODONE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217740-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2024-08-27 A217740-002 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-27 A217740-003 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2024-08-27 A217740-004 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2024-08-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 · 48 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 2026-08-18 06:07:40 2026-07 A217740-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2024-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217740-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217740-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2024-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217740-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2024-08-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217740-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2024-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217740-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217740-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2024-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217740-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2024-08-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217740-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2024-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217740-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217740-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2024-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217740-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2024-08-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217740-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2024-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217740-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217740-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2024-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217740-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2024-08-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217740-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2024-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217740-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217740-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2024-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217740-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2024-08-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217740-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2024-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217740-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217740-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2024-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217740-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2024-08-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217740-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2024-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217740-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217740-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2024-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217740-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2024-08-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217740-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2024-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217740-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217740-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2024-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217740-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2024-08-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217740-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2024-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217740-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217740-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2024-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217740-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2024-08-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217740-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2024-08-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217740-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217740-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2024-08-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217740-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2024-08-27 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TRAZODONE HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRAZODONE HYDROCHLORIDE 100 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856364 Internal RxNorm lookup 856369 Internal RxNorm lookup 856373 Internal RxNorm lookup 856377 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64980-673-01 TRAZODONE HYDROCHLORIDE 100 in 1 BOTTLE TABLET 100 2 64980-673-10 TRAZODONE HYDROCHLORIDE 1000 in 1 BOTTLE TABLET 1000 2 64980-673-50 TRAZODONE HYDROCHLORIDE 500 in 1 BOTTLE TABLET 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-673 TRAZODONE HYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.] 2 Current NDC, 3 package rows 20250515_ef26e4f0-f31f-4efa-9938-28c886cf3d1d.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 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64980-673-01 64980067301 100 TABLET in 1 BOTTLE (64980-673-01) 100 tablet 2025-01-29 No No Current 64980-673-10 64980067310 1000 TABLET in 1 BOTTLE (64980-673-10) 1000 tablet 2025-04-11 No No Current 64980-673-50 64980067350 500 TABLET in 1 BOTTLE (64980-673-50) 500 tablet 2025-01-29 No No Current