Home NDC 72578-181 doxepin
Product NDC 72578-181
11-digit product format 725780181
Labeler code 72578
Product ID 72578-181_d569143c-aee2-4e03-988d-1ef10950e7ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxepin
Dosage form TABLET
Route ORAL
Labeler Viona Pharmaceuticals Inc
Application ANDA202761
Marketing category ANDA
Marketing start 2024-06-30
Substance DOXEPIN HYDROCHLORIDE
Active strength 3 mg/1
Pharmacologic classes Tricyclic Antidepressant [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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202761-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2023-08-16 A202761-002 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2023-08-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 42 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 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2023-08-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2023-08-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2023-08-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2023-08-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2023-08-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2023-08-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2023-08-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2023-08-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2023-08-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2023-08-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2023-08-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2023-08-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2023-08-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2023-08-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2023-08-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2023-08-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL 2023-08-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL 2023-08-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2023-08-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2023-08-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2023-08-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2023-08-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL 2023-08-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL 2023-08-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL 2023-08-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL 2023-08-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL 2023-08-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL 2023-08-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL 2023-08-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL 2023-08-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL 2023-08-16 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL 2023-08-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL 2023-08-16 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL 2023-08-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2023-08-16 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2023-08-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2023-08-16 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2023-08-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202761-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2023-08-16 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202761-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2023-08-16 9b2671bbb829…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base doxepin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXEPIN HYDROCHLORIDE 3 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3U9A0FE9N5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 966787 Internal RxNorm lookup 966793 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72578-181 DOXEPIN TABLET [VIONA PHARMACEUTICALS INC] 2 Current NDC, 7 package rows 20250110_3377541d-db46-4fd9-9a4b-faa5f6108e67.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 72578-181-01 72578018101 100 TABLET in 1 BOTTLE (72578-181-01) 100 tablet 2024-06-30 No No Current 72578-181-05 72578018105 500 TABLET in 1 BOTTLE (72578-181-05) 500 tablet 2024-06-30 No No Current 72578-181-06 72578018106 30 TABLET in 1 BOTTLE (72578-181-06) 30 tablet 2024-06-30 No No Current 72578-181-10 72578018110 1000 TABLET in 1 BOTTLE (72578-181-10) 1000 tablet 2024-06-30 No No Current 72578-181-16 72578018116 90 TABLET in 1 BOTTLE (72578-181-16) 90 tablet 2024-06-30 No No Current 72578-181-77 72578018177 10 BLISTER PACK in 1 CARTON (72578-181-77) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2024-06-30 No No Current