Home NDC 72819-162 Doxepin
Product NDC 72819-162
11-digit product format 728190162
Labeler code 72819
Product ID 72819-162_0e1f91fa-a035-857e-e063-6394a90a68c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxepin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Archis Pharma LLC
Application ANDA202337
Marketing category ANDA
Marketing start 2021-08-01
Substance DOXEPIN HYDROCHLORIDE
Active strength 6 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 A202337-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 A202337-002 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20
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 3 · 84 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 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL 2016-01-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL 2016-01-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202337-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2016-01-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202337-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2016-01-20 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Doxepin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXEPIN HYDROCHLORIDE 6 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72819-162-03 Doxepin 30 in 1 BOTTLE TABLET, FILM COATED 30 3 72819-162-10 Doxepin 100 in 1 BOTTLE TABLET, FILM COATED 100 3 72819-162-11 Doxepin 500 in 1 BOTTLE TABLET, FILM COATED 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72819-162 DOXEPIN TABLET, FILM COATED [ARCHIS PHARMA LLC] 3 Current NDC, Legacy NDC, 3 package rows 20240105_e3eac8e4-224e-4b7b-81d3-071301f914fa.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72819-162-03 72819016203 30 TABLET, FILM COATED in 1 BOTTLE (72819-162-03) 2022-02-21 0000-00-00 No No Current 72819-162-10 72819016210 100 TABLET, FILM COATED in 1 BOTTLE (72819-162-10) 2022-02-21 0000-00-00 No No Current 72819-162-11 72819016211 500 TABLET, FILM COATED in 1 BOTTLE (72819-162-11) 2022-02-21 0000-00-00 No No Current