Home NDC 70518-4733 DOXEPIN HYDROCHLORIDE
Product NDC 70518-4733
11-digit product format 705184733
Labeler code 70518
Product ID 70518-4733_59ca7917-2148-261d-e063-6294a90a7236
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOXEPIN HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA211618
Marketing category ANDA
Marketing start 2026-08-24
Substance DOXEPIN HYDROCHLORIDE
Active strength 150 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 · 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 2026-09-14 22:38:34 2026-08 A211618-001 DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RS 2021-03-01 84e616aacf4f…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# 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 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.
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 70518-4733-0 70518473300 30 CAPSULE in 1 BLISTER PACK (70518-4733-0) 30 capsule 2026-08-24 No No Current