Home NDC 72189-355 Doxepin HCL
Product NDC 72189-355
11-digit product format 721890355
Labeler code 72189
Product ID 72189-355_2c4c85cc-c2b7-ac98-e063-6294a90a973c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxepin HCL
Dosage form CAPSULE
Route ORAL
Labeler Direct_Rx
Application ANDA213063
Marketing category ANDA
Marketing start 2022-05-10
Substance DOXEPIN HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-355-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-355-30 0efc9e666f02…f202fb6c5f17…
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 A213063-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2020-07-01 A213063-002 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 2020-07-01 A213063-003 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2020-07-01 A213063-004 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 2020-07-01 A213063-005 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 2020-07-01
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 · 185 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 A213063-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2020-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213063-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 2020-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213063-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2020-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213063-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 2020-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213063-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 2020-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213063-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2020-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213063-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 2020-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213063-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2020-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213063-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 2020-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213063-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 2020-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213063-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213063-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213063-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2020-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213063-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2020-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213063-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213063-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213063-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213063-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2020-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213063-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2020-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213063-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213063-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213063-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213063-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2020-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213063-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2020-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213063-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213063-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213063-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213063-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2020-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213063-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2020-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213063-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213063-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213063-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213063-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2020-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213063-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2020-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213063-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213063-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213063-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213063-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2020-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213063-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2020-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213063-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-07-01 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 HCL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXEPIN HYDROCHLORIDE 10 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000048 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 72189-355-30 Doxepin HCL 30 in 1 BOTTLE CAPSULE 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-355 DOXEPIN HCL CAPSULE [DIRECT_RX] 3 Current NDC, Legacy NDC, 1 package rows 20250123_dea965fe-6b54-bbf0-e053-2a95a90a1003.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Doxepin HCL DOXEPIN HCL Direct_Rx dea965fe-6b54-bbf0-e053-2a95a90a1003 2025-01-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 213063 application number: ANDA213063 ndc (product): 72189-355 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE direct rx b56cdaee-6187-c763-e053-2995a90acc3f 2025-01-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213063 application number: ANDA213063 Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE Advanced Rx Pharmacy of Tennessee, LLC f900bac4-02f2-6bf3-e053-6394a90a2161 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213063 application number: ANDA213063 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE A-S Medication Solutions 55a20aa1-fc9e-487d-9f8d-c4abf77ae2d2 2024-07-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213063 application number: ANDA213063
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 72189-355-30 72189035530 30 CAPSULE in 1 BOTTLE (72189-355-30) 30 capsule 2022-05-10 0000-00-00 No No Current