Home NDC 54838-512 Doxepin Hydrochloride
Product NDC 54838-512
11-digit product format 548380512
Labeler code 54838
Product ID 54838-512_5408fdf5-16a7-4d5a-b4c4-2ccb271759a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxepin Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA074721
Marketing category ANDA
Marketing start 1998-12-29
Substance DOXEPIN HYDROCHLORIDE
Active strength 10 mg/mL
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 1 .
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 A074721-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29
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 · 41 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 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA 1998-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA 1998-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA 1998-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA 1998-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL RS 1998-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074721-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE / ORAL AA RS 1998-12-29 cb3db0bc1861…
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 10 mg/mL
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 1000054 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 54838-512-40 Doxepin Hydrochloride 120 mL in 1 BOTTLE, PLASTIC SOLUTION 120 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Doxepin Hydrochloride ACTIVE INGREDIENT 3U9A0FE9N5 DOXEPIN HYDROCHLORIDE SOLUTION [SILARX PHARMACEUTICALS, INC] 15 Doxepin ACTIVE MOIETY 5ASJ6HUZ7D DOXEPIN HYDROCHLORIDE SOLUTION [SILARX PHARMACEUTICALS, INC] 15 glycerin INACTIVE INGREDIENT PDC6A3C0OX DOXEPIN HYDROCHLORIDE SOLUTION [SILARX PHARMACEUTICALS, INC] 15 hydrochloric acid INACTIVE INGREDIENT QTT17582CB DOXEPIN HYDROCHLORIDE SOLUTION [SILARX PHARMACEUTICALS, INC] 15 methylparaben INACTIVE INGREDIENT A2I8C7HI9T DOXEPIN HYDROCHLORIDE SOLUTION [SILARX PHARMACEUTICALS, INC] 15 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH DOXEPIN HYDROCHLORIDE SOLUTION [SILARX PHARMACEUTICALS, INC] 15 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I DOXEPIN HYDROCHLORIDE SOLUTION [SILARX PHARMACEUTICALS, INC] 15 water INACTIVE INGREDIENT 059QF0KO0R DOXEPIN HYDROCHLORIDE SOLUTION [SILARX PHARMACEUTICALS, INC] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54838-512 DOXEPIN HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 22 Current NDC, Legacy NDC, 1 package rows 20230411_f350afed-120b-422d-9e6e-3aaa0f72a5fb.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 54838-512-40 54838051240 120 mL in 1 BOTTLE, PLASTIC (54838-512-40) 120 ml 1998-12-29 0000-00-00 No No Current