Home NDC 71335-0072 Doxepin Hydrochloride
Product NDC 71335-0072
11-digit product format 713350072
Labeler code 71335
Product ID 71335-0072_34af79a7-5639-4483-a380-33ad98edb57a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxepin Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA207482
Marketing category ANDA
Marketing start 2017-06-28
Substance DOXEPIN HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A207482-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-06-28 A207482-002 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-06-28 A207482-003 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2017-06-28 A207482-004 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2017-06-28 A207482-005 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-06-28
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 · 215 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 2026-09-14 22:38:34 2026-08 A207482-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207482-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207482-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2017-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207482-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2017-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207482-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-06-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207482-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207482-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207482-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2017-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207482-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2017-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207482-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-06-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207482-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207482-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207482-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2017-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207482-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2017-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207482-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207482-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207482-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207482-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2017-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207482-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2017-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207482-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207482-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207482-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207482-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2017-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207482-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2017-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207482-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207482-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207482-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207482-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2017-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207482-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2017-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207482-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207482-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207482-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207482-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2017-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207482-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2017-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207482-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207482-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207482-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207482-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2017-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207482-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2017-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207482-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-06-28 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 215 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 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 71335-0072-1 2024-05-17 Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only 71335-0072-2 2024-05-17 Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only 71335-0072-3 2024-05-17 Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only 71335-0072-4 2024-05-17 Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only 71335-0072-5 2024-05-17 Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only 71335-0072-1 2024-01-30 Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only 71335-0072-2 2024-01-30 Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only 71335-0072-3 2024-01-30 Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only 71335-0072-4 2024-01-30 Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only 71335-0072-5 2024-01-30 Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-0072-1 Doxepin Hydrochloride 30 in 1 BOTTLE CAPSULE 30 13 71335-0072-2 Doxepin Hydrochloride 60 in 1 BOTTLE CAPSULE 60 13 71335-0072-3 Doxepin Hydrochloride 18 in 1 BOTTLE CAPSULE 18 13 71335-0072-4 Doxepin Hydrochloride 90 in 1 BOTTLE CAPSULE 90 13 71335-0072-5 Doxepin Hydrochloride 180 in 1 BOTTLE CAPSULE 180 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0072 DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] 13 Current NDC, Legacy NDC, 5 package rows 20250221_3bc72772-22ae-4f29-97ff-4a552b4df6d0.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 A-S Medication Solutions 78cf65ff-43f9-4f5e-95dd-864acc89c02a 2026-07-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207482 application number: ANDA207482 Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE Redpharm Drug 37451a61-ccb1-57b3-e063-6294a90a2592 2025-12-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207482 application number: ANDA207482 Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE Major Pharmaceuticals df3b6be0-6a64-4174-b351-dab2061f290e 2025-09-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207482 application number: ANDA207482 Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE Bryant Ranch Prepack 3bc72772-22ae-4f29-97ff-4a552b4df6d0 2025-01-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207482 application number: ANDA207482 ndc (product): 71335-0072 Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE Amneal Pharmaceuticals NY LLC 20bfb8af-7933-4e5c-a2b5-010659d9125b 2024-12-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207482 application number: ANDA207482
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 71335-0072-1 71335007201 30 CAPSULE in 1 BOTTLE (71335-0072-1) 30 capsule 2020-01-22 0000-00-00 No No Current 71335-0072-2 71335007202 60 CAPSULE in 1 BOTTLE (71335-0072-2) 60 capsule 2025-01-28 0000-00-00 No No Current 71335-0072-3 71335007203 18 CAPSULE in 1 BOTTLE (71335-0072-3) 18 capsule 2025-01-28 0000-00-00 No No Current 71335-0072-4 71335007204 90 CAPSULE in 1 BOTTLE (71335-0072-4) 90 capsule 2025-01-28 0000-00-00 No No Current 71335-0072-5 71335007205 180 CAPSULE in 1 BOTTLE (71335-0072-5) 180 capsule 2025-01-28 0000-00-00 No No Current