Home NDC 69238-1733 Doxepin Hydrochloride
Product NDC 69238-1733
11-digit product format 692381733
Labeler code 69238
Product ID 69238-1733_f44f392e-0f43-4e5d-a2c4-0b15387d67ac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxepin Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA212357
Marketing category ANDA
Marketing start 2023-08-21
Substance DOXEPIN HYDROCHLORIDE
Active strength 50 mg/g
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 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 A212357-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212357-001 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 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212357-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2023-08-16 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXEPIN HYDROCHLORIDE 50 mg/g
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 1000091 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 69238-1733-6 Doxepin Hydrochloride 1 in 1 CARTON CREAM 1 8 69238-1733-6 Doxepin Hydrochloride 45 g in 1 TUBE CREAM 45 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1733 DOXEPIN HYDROCHLORIDE CREAM [AMNEAL PHARMACEUTICALS NY LLC] 8 Current NDC, 2 package rows 20250427_dd8d5edd-7b08-4061-86e6-c4179da89c0d.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 · 1 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 69238-1733-6 69238173306 1 TUBE in 1 CARTON (69238-1733-6) / 45 g in 1 TUBE 1 tube 2023-08-21 No No Current