Home NDC 85437-004-60 Ertaczo
Product NDC 85437-004
Requested package NDC 85437-004-60
11-digit product format 854370004
Labeler code 85437
Product ID 85437-004_4ee1de22-cab4-606f-e063-6394a90afd63
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sertaconazole Nitrate
Dosage form CREAM
Route TOPICAL
Labeler Coral Way Pharma, LLC
Application NDA021385
Marketing category NDA
Marketing start 2025-11-07
Substance SERTACONAZOLE NITRATE
Active strength 20 mg/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
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 1 .
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 N021385-001 ERTACZO SERTACONAZOLE NITRATE 2% CREAM / TOPICAL RLD, RS 2003-12-10
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 · 41 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 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021385-001 ERTACZO 2% CREAM / TOPICAL RLD, RS 2003-12-10 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Ertaczo
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SERTACONAZOLE NITRATE 20 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1DV05410M5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 250511 Internal RxNorm lookup 580294 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 85437-004-60 Ertaczo 60 g in 1 TUBE CREAM 60 2 85437-004-60 Ertaczo 1 in 1 CARTON CREAM 1 2
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 · 2 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 85437-004-60 85437000460 1 TUBE in 1 CARTON (85437-004-60) / 60 g in 1 TUBE 1 tube 2025-11-07 No No Current