Terbinafine

Product NDC: 68071-4712
11-digit product format: 680714712
Labeler code: 68071
Product ID: 68071-4712_bb8c436d-fa68-2cbb-e053-2a95a90ae9e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Terbinafine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA078297
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: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-4712		D	Discontinued by firm		2026-08-17
excluded package	package	68071-4712	68071-4712-3	D	Discontinued by firm		2026-08-17

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 · 30 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	68071-4712-3	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	68071-4712-3	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	68071-4712-3	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	68071-4712-3	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	68071-4712-3	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	68071-4712-3	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	68071-4712-3	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	68071-4712-3	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	68071-4712-3	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-4712-3	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-4712-3	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-4712-3	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-4712-3	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-4712-3	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-4712-3	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
A078297-001	TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078297-001	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	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078297-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078297-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078297-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078297-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078297-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078297-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078297-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078297-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078297-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078297-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078297-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078297-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078297-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078297-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078297-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078297-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078297-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078297-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078297-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078297-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078297-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078297-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078297-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078297-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078297-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078297-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078297-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078297-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078297-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078297-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078297-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078297-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078297-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078297-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078297-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078297-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078297-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078297-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078297-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078297-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-12	These highlights do not include all the information needed to use TERBINAFINE TABLETS safely and effectively. See full prescribing information for TERBINAFINE TABLETS. TERBINAFINE tablets, for oral use Initial U.S. Approval: 1992
2023-01-30	These highlights do not include all the information needed to use TERBINAFINE TABLETS safely and effectively. See full prescribing information for TERBINAFINE TABLETS. TERBINAFINE tablets, for oral use Initial U.S. Approval: 1992
2021-02-17	These highlights do not include all the information needed to use TERBINAFINE TABLETS safely and effectively. See full prescribing information for TERBINAFINE TABLETS. TERBINAFINE tablets, for oral use Initial U.S. Approval: 1992
2021-01-29	These highlights do not include all the information needed to use TERBINAFINE TABLETS safely and effectively. See full prescribing information for TERBINAFINE TABLETS. TERBINAFINE tablets, for oral use Initial U.S. Approval: 1992

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terbinafine	TERBINAFINE HYDROCHLORIDE	American Health Packaging	4ee1b667-0cf6-46e4-a740-4fc27904d577	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	REMEDYREPACK INC.	44c6f6e7-e0c0-450e-83ce-1ed4f3efddec	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	A-S Medication Solutions	5de4c245-7086-453b-b90a-7a1242ec2c0b	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	747fdc13-7c3a-4672-b50c-31c51037bda2	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	085e0809-6b7f-447e-976e-8276c29daad6	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	Bryant Ranch Prepack	838c6140-19b6-4c2b-aed7-3065bd67af07	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
TERBINAFINE	TERBINAFINE	direct rx	c7cf55e2-f637-e2d9-e053-2995a90a6270	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	Proficient Rx LP	0a54cc4f-0789-46ce-875f-df759aa95d9c	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	87af930f-493c-590e-e053-2a95a90a804a	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	Bryant Ranch Prepack	294bc1af-50e3-4bff-8d48-321e673033ce	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	A-S Medication Solutions	79a39fb1-12b7-4b1e-9f28-102af34d0459	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	Aurobindo Pharma Limited	6600e2b3-65df-4fc3-8081-d574537d27e3	2024-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	NorthStar Rx LLC	8f87e3e1-4c9c-497a-af20-8ab52cfeef60	2024-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	Proficient Rx LP	50657431-1cd9-42dd-9cfc-57db8713d267	2024-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297

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
68071-4712-3	68071471203	30 TABLET in 1 BOTTLE (68071-4712-3)	30 tablet	2019-01-15	0000-00-00	No	No	Current