Home NDC 0904-6972-61 Doxepin Hydrochloride
Product NDC 0904-6972
Requested package NDC 0904-6972-61
11-digit product format 009046972
Labeler code 0904
Product ID 0904-6972_41d8f133-97e0-4e9f-ae57-3ef063e24121
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxepin Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA071422
Marketing category ANDA
Marketing start 2017-09-01
Marketing end 2022-02-28
Substance DOXEPIN HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071422-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 1987-11-09 A071422-002 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 1987-11-09 A071422-003 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 1987-11-09 A071422-004 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 1987-11-09 A071422-005 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 1987-11-09 A071422-006 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RS 1987-11-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071422-006 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.
Product history page 1 of 7 · 241 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 A071422-001 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 1987-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071422-002 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 1987-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071422-003 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 1987-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071422-004 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 1987-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071422-005 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 1987-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071422-006 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RS 1987-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071422-001 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 1987-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071422-002 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 1987-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071422-003 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 1987-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071422-004 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 1987-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071422-005 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 1987-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071422-006 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RS 1987-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071422-001 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 1987-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071422-002 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 1987-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071422-003 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 1987-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071422-004 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 1987-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071422-005 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 1987-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071422-006 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RS 1987-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071422-001 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 1987-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071422-002 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 1987-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071422-003 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 1987-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071422-004 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 1987-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071422-005 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 1987-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071422-006 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RS 1987-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071422-001 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 1987-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071422-002 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 1987-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071422-003 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 1987-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071422-004 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 1987-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071422-005 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 1987-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071422-006 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RS 1987-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071422-001 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 1987-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071422-002 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 1987-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071422-003 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 1987-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071422-004 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 1987-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071422-005 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 1987-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071422-006 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RS 1987-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071422-001 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 1987-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071422-002 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 1987-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071422-003 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 1987-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071422-004 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 1987-11-09 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 107 observed states.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-6972-61 00904697261 100 BLISTER PACK in 1 CARTON (0904-6972-61) > 1 CAPSULE in 1 BLISTER PACK 100 blister pack 2017-09-01 2022-02-28 No No Current