Home NDC 69315-163 DOXEPIN HYDROCHLORIDE
Product NDC 69315-163
11-digit product format 693150163
Labeler code 69315
Product ID 69315-163_ab05177e-b4a4-4cc5-b950-441858aaa0ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOXEPIN HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler Leading Pharma, LLC
Application ANDA211618
Marketing category ANDA
Marketing start 2021-04-15
Substance DOXEPIN HYDROCHLORIDE
Active strength 150 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211618-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RS 2021-03-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211618-001 AB
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.
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 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RS 2021-03-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2021-03-01 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base DOXEPIN HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXEPIN HYDROCHLORIDE 150 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 1000064 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 69315-163-01 DOXEPIN HYDROCHLORIDE 100 in 1 PACKAGE CAPSULE 100 6 69315-163-05 DOXEPIN HYDROCHLORIDE 500 in 1 PACKAGE CAPSULE 500 6 69315-163-50 DOXEPIN HYDROCHLORIDE 50 in 1 PACKAGE CAPSULE 50 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69315-163 DOXEPIN HYDROCHLORIDE CAPSULE [LEADING PHARMA, LLC] 5 Current NDC, Legacy NDC, 3 package rows 20241009_d5df4beb-8048-4b83-aa59-19876437001d.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 · 1 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 69315-163-01 69315016301 100 CAPSULE in 1 PACKAGE (69315-163-01) 100 capsule 2021-04-15 0000-00-00 No No Current 69315-163-05 69315016305 500 CAPSULE in 1 PACKAGE (69315-163-05) 500 capsule 2021-04-15 0000-00-00 No No Current 69315-163-50 69315016350 50 CAPSULE in 1 PACKAGE (69315-163-50) 50 capsule 2021-04-15 0000-00-00 No No Current