Home NDC 72789-220-90 Doxepin Hydrochloride
Product NDC 72789-220
Requested package NDC 72789-220-90
11-digit product format 727890220
Labeler code 72789
Product ID 72789-220_5ec2990b-8182-3d8e-e063-6294a90ab1b2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxepin Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA211603
Marketing category ANDA
Marketing start 2019-03-27
Substance DOXEPIN HYDROCHLORIDE
Active strength 10 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 45 .
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 A211603-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2019-03-27 A211603-002 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2019-03-27 A211603-003 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2019-03-27 A211603-004 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2019-03-27 A211603-005 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2019-03-27
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 6 · 225 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 2026-11-14 07:37:17 2026-10 A211603-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2019-03-27 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A211603-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2019-03-27 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A211603-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2019-03-27 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A211603-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2019-03-27 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A211603-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2019-03-27 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A211603-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2019-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211603-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2019-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211603-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2019-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211603-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2019-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211603-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2019-03-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A211603-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2019-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211603-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2019-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211603-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2019-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211603-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2019-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211603-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2019-03-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211603-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2019-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211603-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2019-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211603-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2019-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211603-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2019-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211603-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2019-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211603-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2019-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211603-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2019-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211603-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2019-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211603-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2019-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211603-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2019-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211603-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2019-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211603-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2019-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211603-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2019-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211603-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2019-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211603-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2019-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211603-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2019-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211603-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2019-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211603-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2019-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211603-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2019-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211603-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2019-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211603-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2019-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211603-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2019-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211603-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2019-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211603-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2019-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211603-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2019-03-27 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 225 observed states.
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 10 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 1000048 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 72789-220-30 Doxepin Hydrochloride 30 in 1 BOTTLE, PLASTIC CAPSULE 30 9 72789-220-90 Doxepin Hydrochloride 90 in 1 BOTTLE, PLASTIC CAPSULE 90 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-220 DOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20250105_2bf7d838-6274-4d8a-91cb-b27e1e81d273.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE PD-Rx Pharmaceuticals, Inc. 1496dfc1-de50-471c-be87-1f1e2b70ab5a 2025-12-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211603 application number: ANDA211603 Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE Aurobindo Pharma Limited f3c242dd-426e-4c69-8f21-2645361d5f27 2025-09-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211603 application number: ANDA211603 Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE NuCare Pharmaceuticals,Inc. 9ee26b24-7121-3107-e053-2995a90ac61c 2024-06-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211603 application number: ANDA211603 Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE Proficient Rx LP 6ce7fde2-2d47-4238-9beb-555d352f4657 2022-05-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211603 application number: ANDA211603 Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE Proficient Rx LP e98f371e-f7fe-4c8f-9491-6eb4c53d43ad 2021-02-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211603 application number: ANDA211603
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72789-220-90 72789022090 90 CAPSULE in 1 BOTTLE, PLASTIC (72789-220-90) 90 capsule 2024-09-06 No No Current