NAFTIFINE HYDROCHLORIDE

Product NDC
0115-1510
11-digit product format
001151510
Labeler code
0115
Product ID
0115-1510_eaabbf9e-b49d-4d23-bd49-8bc5aaee3967
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAFTIFINE HYDROCHLORIDE
Dosage form
GEL
Route
TOPICAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA206165
Marketing category
ANDA
Marketing start
2019-03-20
Marketing end
0000-00-00
Substance
NAFTIFINE HYDROCHLORIDE
Active strength
10 mg/g
Pharmacologic classes
Allylamine [CS],Allylamine Antifungal [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0115-1510DDiscontinued by firm2026-08-07
excluded packagepackage0115-15100115-1510-48DDiscontinued by firm2026-08-07
excluded packagepackage0115-15100115-1510-58DDiscontinued by firm2026-08-07
excluded packagepackage0115-15100115-1510-63DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0115-1510-48d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0115-1510-58d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0115-1510-63d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0115-1510-48f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0115-1510-58f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0115-1510-63f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0115-1510-482ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0115-1510-582ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0115-1510-632ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0115-1510-48a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0115-1510-58a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0115-1510-63a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0115-1510-48cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0115-1510-58cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0115-1510-63cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0115-1510-48cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0115-1510-58cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0115-1510-63cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0115-1510-48302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0115-1510-58302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0115-1510-63302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0115-1510-48ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0115-1510-58ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0115-1510-63ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0115-1510-480efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0115-1510-580efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0115-1510-630efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0115-1510-48ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0115-1510-58ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0115-1510-63ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0115-1510-48367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0115-1510-58367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0115-1510-63367a005e9d99…383a685ebd0f…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206165-001NAFTIFINE HYDROCHLORIDENAFTIFINE HYDROCHLORIDE1%GEL / TOPICAL2019-03-20

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-203f01610625f2…
2019-09-15 20:21 UTC2019-09A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206165-001NAFTIFINE HYDROCHLORIDE1%GEL / TOPICALAB2019-03-20cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206165-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206165-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206165-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206165-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206165-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206165-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206165-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206165-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206165-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206165-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206165-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206165-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206165-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206165-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206165-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206165-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206165-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206165-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206165-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206165-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206165-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A206165-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206165-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206165-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206165-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A206165-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206165-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206165-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206165-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206165-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206165-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206165-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206165-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206165-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206165-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206165-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206165-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206165-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206165-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206165-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1510-48GM - Gram0115-15107f7419c9-19a1-43fc-8395-3ca04f0bea4012019-06-19
0115-1510-58GM - Gram0115-15109cef488f-2298-4fee-8bfe-a651681a887412019-06-19
0115-1510-63GM - Gram0115-15101136483c-5d7f-470c-bdc6-96cd700b7c1d12019-06-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1510-48001151510481 TUBE in 1 CARTON (0115-1510-48) > 90 g in 1 TUBE1 tube2019-03-200000-00-00NoNoCurrent
0115-1510-58001151510581 TUBE in 1 CARTON (0115-1510-58) > 60 g in 1 TUBE1 tube2019-03-200000-00-00NoNoCurrent
0115-1510-63001151510631 TUBE in 1 CARTON (0115-1510-63) > 40 g in 1 TUBE1 tube2019-03-200000-00-00NoNoCurrent