Home NDC 64679-743 TERBINAFINE HYDROCHLORIDE
Product NDC 64679-743
11-digit product format 646790743
Labeler code 64679
Product ID 64679-743_e1cc2722-d25c-4feb-8934-8d22dcf6c535
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name terbinafine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Wockhardt USA LLC.
Application ANDA078229
Marketing category ANDA
Marketing start 2007-07-02
Marketing end 0000-00-00
Substance TERBINAFINE HYDROCHLORIDE
Active strength 250 mg/1
Pharmacologic classes Allylamine [CS],Allylamine Antifungal [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 2 · 75 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-743-03 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-743-04 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-743-02 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-743-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-743-03 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-743-04 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-743-02 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-743-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-743-03 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-743-04 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-743-02 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-743-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-743-03 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-743-04 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-743-02 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-743-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-743-03 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-743-04 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-743-02 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-743-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-743-03 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-743-04 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-743-02 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-743-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-743-03 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-743-04 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-743-02 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-743-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-743-03 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-743-04 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-743-02 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-743-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-743-03 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-743-04 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-743-02 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-743-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-743-02 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-743-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-743-03 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-743-04 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-743-02 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-743-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-743-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-743-04 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-743-02 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-743-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-743-03 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-743-04 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A078229-001 TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02
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 · 43 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 2026-09-14 22:38:34 2026-08 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078229-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 64679-743-01 2024-11-13 These highlights do not include all the information needed to use TERBINAFINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TERBINAFINE HYDROCHLORIDE TABLETS. TERBINAFINE hydrochloride tablets, for oral use Initial U.S. Approval: 1992 64679-743-02 2024-11-13 These highlights do not include all the information needed to use TERBINAFINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TERBINAFINE HYDROCHLORIDE TABLETS. TERBINAFINE hydrochloride tablets, for oral use Initial U.S. Approval: 1992 64679-743-03 2024-11-13 These highlights do not include all the information needed to use TERBINAFINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TERBINAFINE HYDROCHLORIDE TABLETS. TERBINAFINE hydrochloride tablets, for oral use Initial U.S. Approval: 1992 64679-743-04 2024-11-13 These highlights do not include all the information needed to use TERBINAFINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TERBINAFINE HYDROCHLORIDE TABLETS. TERBINAFINE hydrochloride tablets, for oral use Initial U.S. Approval: 1992 64679-743-01 2023-01-30 These highlights do not include all the information needed to use TERBINAFINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TERBINAFINE HYDROCHLORIDE TABLETS. TERBINAFINE hydrochloride tablets, for oral use Initial U.S. Approval: 1992 64679-743-02 2023-01-30 These highlights do not include all the information needed to use TERBINAFINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TERBINAFINE HYDROCHLORIDE TABLETS. TERBINAFINE hydrochloride tablets, for oral use Initial U.S. Approval: 1992 64679-743-03 2023-01-30 These highlights do not include all the information needed to use TERBINAFINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TERBINAFINE HYDROCHLORIDE TABLETS. TERBINAFINE hydrochloride tablets, for oral use Initial U.S. Approval: 1992 64679-743-04 2023-01-30 These highlights do not include all the information needed to use TERBINAFINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TERBINAFINE HYDROCHLORIDE TABLETS. TERBINAFINE hydrochloride tablets, for oral use Initial U.S. Approval: 1992
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64679-743-01 64679074301 30 TABLET in 1 BOTTLE (64679-743-01) 30 tablet 2007-07-02 0000-00-00 No No Current 64679-743-02 64679074302 1000 TABLET in 1 BOTTLE (64679-743-02) 1000 tablet 2007-07-02 0000-00-00 No No Current 64679-743-03 64679074303 100 TABLET in 1 BOTTLE (64679-743-03) 100 tablet 2007-07-02 0000-00-00 No No Current 64679-743-04 64679074304 10 BLISTER PACK in 1 CARTON (64679-743-04) > 10 TABLET in 1 BLISTER PACK 10 blister pack 2007-07-02 0000-00-00 No No Current