Home NDC 0378-8123 Zonalon
Product NDC 0378-8123
11-digit product format 003788123
Labeler code 0378
Product ID 0378-8123_d08db934-a9ce-4b1a-9ca1-5c6705b227a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxepin hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA020126
Marketing category NDA
Marketing start 2018-11-14
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 42 .
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 N020126-001 ZONALON DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB RLD, RS 1994-04-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020126-001 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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020126-001 ZONALON 5% CREAM / TOPICAL AB RLD, RS 1994-04-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020126-001 ZONALON 5% CREAM / TOPICAL RLD, RS 1994-04-01 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Zonalon
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000091 Internal RxNorm lookup 1000095 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-8123 ZONALON (DOXEPIN HYDROCHLORIDE) CREAM [MYLAN PHARMACEUTICALS INC.] 3 Current NDC, Legacy NDC, 4 package rows 20181127_5f302247-525e-4acc-852b-00eb1d79af4b.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 · 3 matching rows.
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 0378-8123-30 00378812330 1 TUBE in 1 CARTON (0378-8123-30) / 30 g in 1 TUBE 1 tube 2018-11-26 0000-00-00 No No Current 0378-8123-45 00378812345 1 TUBE in 1 CARTON (0378-8123-45) / 45 g in 1 TUBE 1 tube 2018-11-14 0000-00-00 No No Current