TERBINAFINE HYDROCHLORIDE

Product NDC: 64679-743
Requested package NDC: 64679-743-04
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	64679-743	64679-743-04	D	Discontinued by firm		2026-10-05

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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64679-743-01	EA - Each	64679-743	ae8e7806-34c1-4ff4-9955-2e74555dc8c2	1	2013-02-13
64679-743-03	EA - Each	64679-743	129009cc-f87f-4699-9087-7ed56c37fcc0	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TERBINAFINE HYDROCHLORIDE	ACTIVE INGREDIENT	012C11ZU6G	TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]	1
TERBINAFINE	ACTIVE MOIETY	G7RIW8S0XP	TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
012C11ZU6G	TERBINAFINE HYDROCHLORIDE	78628-80-5	TERBINAFINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64679-743-04	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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TERBINAFINE HYDROCHLORIDE	Wockhardt USA LLC. \| Wockhardt Limited	2019-11-26	HUMAN PRESCRIPTION DRUG LABEL	3