Home NDC 50090-5286 DOXEPIN HYDROCHLORIDE
Product NDC 50090-5286
11-digit product format 500905286
Labeler code 50090
Product ID 50090-5286_21a943cc-60a8-474b-a2af-5a953bc57e61
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOXEPIN HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA213063
Marketing category ANDA
Marketing start 2020-07-01
Substance DOXEPIN HYDROCHLORIDE
Active strength 50 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 A213063-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2020-07-01 A213063-002 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 2020-07-01 A213063-003 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2020-07-01 A213063-004 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 2020-07-01 A213063-005 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 2020-07-01
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 A213063-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2020-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213063-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 2020-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213063-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2020-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213063-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 2020-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213063-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 2020-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213063-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2020-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213063-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL 2020-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213063-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2020-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213063-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL 2020-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213063-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL 2020-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213063-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213063-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213063-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2020-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213063-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2020-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213063-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213063-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213063-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213063-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2020-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213063-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2020-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213063-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213063-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213063-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213063-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2020-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213063-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2020-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213063-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213063-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213063-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213063-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2020-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213063-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2020-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213063-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213063-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213063-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213063-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2020-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213063-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2020-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213063-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213063-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2020-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213063-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2020-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213063-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2020-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213063-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2020-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213063-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2020-07-01 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 50 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 1000076 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-5286-0 DOXEPIN HYDROCHLORIDE 100 in 1 BOTTLE CAPSULE 100 5 50090-5286-1 DOXEPIN HYDROCHLORIDE 30 in 1 BOTTLE CAPSULE 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5286 DOXEPIN HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS] 5 Current NDC, Legacy NDC, 2 package rows 20240731_55a20aa1-fc9e-487d-9f8d-c4abf77ae2d2.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Doxepin HCL DOXEPIN HCL Direct_Rx dea965fe-6b54-bbf0-e053-2a95a90a1003 2025-01-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 213063 application number: ANDA213063 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE direct rx b56cdaee-6187-c763-e053-2995a90acc3f 2025-01-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213063 application number: ANDA213063 Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE Advanced Rx Pharmacy of Tennessee, LLC f900bac4-02f2-6bf3-e053-6394a90a2161 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213063 application number: ANDA213063 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE A-S Medication Solutions 55a20aa1-fc9e-487d-9f8d-c4abf77ae2d2 2024-07-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213063 application number: ANDA213063 ndc (product): 50090-5286
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-5286-0 50090528600 100 CAPSULE in 1 BOTTLE (50090-5286-0) 100 capsule 2020-10-22 No No Current 50090-5286-1 50090528601 30 CAPSULE in 1 BOTTLE (50090-5286-1) 30 capsule 2020-10-22 0000-00-00 No No Current