Home NDC 0527-4064 Doxepin Hydrochloride
Product NDC 0527-4064
11-digit product format 005274064
Labeler code 0527
Product ID 0527-4064_deea4759-8189-4dd3-8d07-99b569e2206b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxepin Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA212997
Marketing category ANDA
Marketing start 2020-07-24
Marketing end 0000-00-00
Substance DOXEPIN HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A212997-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2020-07-24 A212997-002 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 2020-07-24 A212997-003 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2020-07-24 A212997-004 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 2020-07-24 A212997-005 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 2020-07-24
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 A212997-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212997-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212997-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212997-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212997-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 2020-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212997-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2020-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212997-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 2020-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212997-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2020-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212997-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 2020-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212997-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 2020-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212997-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2020-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212997-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 2020-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212997-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2020-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212997-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 2020-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212997-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 2020-07-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212997-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2020-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212997-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 2020-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212997-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2020-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212997-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 2020-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212997-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 2020-07-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212997-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2020-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212997-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 2020-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212997-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2020-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212997-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 2020-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212997-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 2020-07-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212997-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2020-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212997-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 2020-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212997-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2020-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212997-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 2020-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212997-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 2020-07-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212997-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2020-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212997-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 2020-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212997-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2020-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212997-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 2020-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212997-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 2020-07-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212997-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2020-07-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212997-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 2020-07-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212997-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2020-07-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212997-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 2020-07-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212997-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 2020-07-24 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0527-4064-37 00527406437 100 CAPSULE in 1 BOTTLE (0527-4064-37) 100 capsule 2020-07-24 0000-00-00 No No Current 0527-4064-43 00527406443 1000 CAPSULE in 1 BOTTLE (0527-4064-43) 1000 capsule 2020-07-24 0000-00-00 No No Current