Home NDC 24658-794-01 Doxepin Hydrochloride
Product NDC 24658-794
Requested package NDC 24658-794-01
11-digit product format 246580794
Labeler code 24658
Product ID 24658-794_14002bad-2577-436d-91ca-ec1b80ab0c97
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxepin Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
Application ANDA210675
Marketing category ANDA
Marketing start 2023-03-14
Substance DOXEPIN HYDROCHLORIDE
Active strength 25 mg/1
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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210675-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-10-16 A210675-002 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-10-16 A210675-003 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-10-16 A210675-004 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2022-03-03 A210675-005 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2022-03-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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.
Product history page 1 of 5 · 170 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 A210675-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210675-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210675-003 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210675-004 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2022-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210675-005 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2022-03-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210675-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210675-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210675-003 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210675-004 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2022-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210675-005 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2022-03-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210675-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210675-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210675-003 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210675-004 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2022-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210675-005 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2022-03-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210675-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210675-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210675-003 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210675-004 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2022-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210675-005 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2022-03-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210675-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210675-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210675-003 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210675-004 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2022-03-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210675-005 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2022-03-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210675-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210675-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210675-003 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210675-004 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2022-03-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210675-005 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2022-03-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210675-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210675-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210675-003 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210675-004 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2022-03-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210675-005 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2022-03-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210675-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210675-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210675-003 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210675-004 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2022-03-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210675-005 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2022-03-03 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 170 observed states.
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 25 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000048 Internal RxNorm lookup 1000058 Internal RxNorm lookup 1000070 Internal RxNorm lookup 1000076 Internal RxNorm lookup 1000097 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 24658-794-01 Doxepin Hydrochloride 100 in 1 BOTTLE CAPSULE 100 1 24658-794-10 Doxepin Hydrochloride 1000 in 1 BOTTLE CAPSULE 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24658-794 DOXEPIN HYDROCHLORIDE CAPSULE [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS] 1 Current NDC, 2 package rows 20230318_14002bad-2577-436d-91ca-ec1b80ab0c97.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 24658-794-01 24658079401 100 CAPSULE in 1 BOTTLE (24658-794-01) 100 capsule 2023-03-14 No No Current