Home NDC 51407-728 doxepin hydrochloride
Product NDC 51407-728
11-digit product format 514070728
Labeler code 51407
Product ID 51407-728_57efdac6-7c96-5ff1-e063-6294a90adb10
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxepin hydrochloride
Dosage form TABLET
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA219058
Marketing category ANDA
Marketing start 2025-08-06
Substance DOXEPIN HYDROCHLORIDE
Active strength 6 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219058-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2025-08-06 A219058-002 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2025-08-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-09-14 22:38:34 2026-08 A219058-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2025-08-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219058-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2025-08-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219058-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2025-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219058-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2025-08-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219058-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2025-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219058-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2025-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219058-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2025-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219058-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2025-08-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219058-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2025-08-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219058-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2025-08-06 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219058-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2025-08-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219058-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2025-08-06 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base doxepin hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXEPIN HYDROCHLORIDE 6 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 966787 Internal RxNorm lookup 966793 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51407-728-30 51407072830 30 TABLET in 1 BOTTLE (51407-728-30) 30 tablet 2026-04-20 No No Current