Home NDC 51672-1368 Naftifine Hydrochloride
Product NDC 51672-1368
11-digit product format 516721368
Labeler code 51672
Product ID 51672-1368_438dc98f-5e1f-b739-e063-6294a90a87a4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naftifine Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA206901
Marketing category ANDA
Marketing start 2016-01-06
Substance NAFTIFINE HYDROCHLORIDE
Active strength 20 mg/g
Pharmacologic classes Allylamine Antifungal [EPC], Allylamine [CS]
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 A206901-001 NAFTIFINE HYDROCHLORIDE NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206901-001 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 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206901-001 NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB 2016-01-06 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Naftifine Hydrochloride
Listing expiration 2026-12-31 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 1246096 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 51672-1368-2 Naftifine Hydrochloride 30 g in 1 TUBE CREAM 30 7 51672-1368-2 Naftifine Hydrochloride 1 in 1 CARTON CREAM 1 7 51672-1368-3 Naftifine Hydrochloride 1 in 1 CARTON CREAM 1 7 51672-1368-3 Naftifine Hydrochloride 60 g in 1 TUBE CREAM 60 7 51672-1368-6 Naftifine Hydrochloride 45 g in 1 TUBE CREAM 45 7 51672-1368-6 Naftifine Hydrochloride 1 in 1 CARTON CREAM 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1368 NAFTIFINE HYDROCHLORIDE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 Current NDC, Legacy NDC, 6 package rows 20250529_a740fc0d-45b3-411f-9dfd-f3d637b8a95f.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 51672-1368-2 51672136802 1 TUBE in 1 CARTON (51672-1368-2) / 30 g in 1 TUBE 1 tube 2016-01-06 0000-00-00 No No Current 51672-1368-3 51672136803 1 TUBE in 1 CARTON (51672-1368-3) / 60 g in 1 TUBE 1 tube 2016-01-06 0000-00-00 No No Current 51672-1368-6 51672136806 1 TUBE in 1 CARTON (51672-1368-6) / 45 g in 1 TUBE 1 tube 2016-01-06 0000-00-00 No No Current