Home NDC 23155-795 DOXEPIN HYDROCHLORIDE
Product NDC 23155-795
11-digit product format 231550795
Labeler code 23155
Product ID 23155-795_b170c5a1-48e2-4532-8324-cce5229fe09b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOXEPIN HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application ANDA214908
Marketing category ANDA
Marketing start 2021-12-30
Substance DOXEPIN HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Tricyclic Antidepressant [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 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214908-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2021-04-01 A214908-002 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2021-04-01 A214908-003 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2021-04-01 A214908-004 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2021-04-01 A214908-005 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2021-04-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 5 · 170 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 2026-02-19 14:30 UTC 2026-02 A214908-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2021-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214908-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2021-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214908-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2021-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214908-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2021-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214908-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2021-04-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214908-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2021-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214908-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2021-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214908-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2021-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214908-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2021-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214908-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2021-04-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214908-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2021-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214908-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2021-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214908-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2021-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214908-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2021-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214908-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2021-04-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214908-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2021-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214908-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2021-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214908-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2021-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214908-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2021-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214908-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2021-04-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214908-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2021-04-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214908-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2021-04-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214908-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2021-04-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214908-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2021-04-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214908-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2021-04-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214908-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2021-04-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214908-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2021-04-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214908-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2021-04-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214908-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2021-04-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214908-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2021-04-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214908-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2021-04-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214908-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2021-04-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214908-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2021-04-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214908-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2021-04-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214908-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2021-04-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214908-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2021-04-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214908-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2021-04-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214908-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2021-04-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214908-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2021-04-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214908-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2021-04-01 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 170 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DOXEPIN HYDROCHLORIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXEPIN 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 3U9A0FE9N5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000048 Internal RxNorm lookup 1000058 Internal RxNorm lookup 1000070 Internal RxNorm lookup 1000076 Internal RxNorm lookup 1000097 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 23155-795-01 DOXEPIN HYDROCHLORIDE 100 in 1 BOTTLE CAPSULE 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 23155-795 DOXEPIN HYDROCHLORIDE CAPSULE DOXEPIN HYDROCHLORIDE (DOXEPN HYDROCHLORIDE) CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] 1 Current NDC, Legacy NDC, 1 package rows 20211230_89ed6385-cf6a-458e-81ea-c7f3fead41c5.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 Marketing end Sample Exclude flag Status 23155-795-01 23155079501 100 CAPSULE in 1 BOTTLE (23155-795-01) 100 capsule 2021-12-30 0000-00-00 No No Current