Home NDC 51672-1376 Naftifine Hydrochloride
Product NDC 51672-1376
11-digit product format 516721376
Labeler code 51672
Product ID 51672-1376_4aa35016-7749-87c7-e063-6394a90ac5c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naftifine Hydrochloride
Dosage form GEL
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA208201
Marketing category ANDA
Marketing start 2023-04-01
Substance NAFTIFINE HYDROCHLORIDE
Active strength 20 mg/g
Pharmacologic classes Allylamine Antifungal [EPC], Allylamine [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 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 A208201-001 NAFTIFINE HYDROCHLORIDE NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208201-001 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 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL AB 2019-04-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208201-001 NAFTIFINE HYDROCHLORIDE 2% GEL / TOPICAL 2019-04-10 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Naftifine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAFTIFINE HYDROCHLORIDE 20 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 25UR9N9041 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1433734 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 51672-1376-3 Naftifine Hydrochloride 60 g in 1 TUBE GEL 60 11 51672-1376-3 Naftifine Hydrochloride 1 in 1 CARTON GEL 1 11 51672-1376-6 Naftifine Hydrochloride 45 g in 1 TUBE GEL 45 11 51672-1376-6 Naftifine Hydrochloride 1 in 1 CARTON GEL 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1376 NAFTIFINE HYDROCHLORIDE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 9 Current NDC, Legacy NDC, 4 package rows 20230401_92d3ec30-2176-49cd-8a70-668ef65e7663.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 Marketing end Sample Exclude flag Status 51672-1376-3 51672137603 1 TUBE in 1 CARTON (51672-1376-3) / 60 g in 1 TUBE 1 tube 2023-04-01 0000-00-00 No No Current 51672-1376-6 51672137606 1 TUBE in 1 CARTON (51672-1376-6) / 45 g in 1 TUBE 1 tube 2023-04-01 0000-00-00 No No Current