Terbinafine Hydrochloride

Product NDC: 70518-1743
11-digit product format: 705181743
Labeler code: 70518
Product ID: 70518-1743_c4407ed9-0672-0ba9-e053-2995a90a3883
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Terbinafine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA077714
Marketing category: ANDA
Marketing start: 2018-12-18
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-1743		D	Discontinued by firm	2026-08-07
excluded package	package	70518-1743	70518-1743-0	D	Discontinued by firm	2026-08-07
excluded package	package	70518-1743	70518-1743-1	D	Discontinued by firm	2026-08-07

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 · 34 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1743-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1743-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1743-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1743-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-1743-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-1743-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-1743-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-1743-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-1743-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-1743-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-1743-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-1743-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-1743-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-1743-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1743-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1743-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1743-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1743-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-1743-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-1743-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-1743-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-1743-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-1743-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077714-001	TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL			2010-06-04

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2010-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2010-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2010-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077714-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077714-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077714-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077714-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077714-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077714-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077714-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077714-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077714-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077714-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077714-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077714-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077714-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077714-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077714-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077714-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077714-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077714-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077714-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077714-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077714-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077714-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077714-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077714-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077714-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077714-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077714-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077714-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077714-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077714-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077714-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077714-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077714-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077714-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077714-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077714-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077714-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-1743-0	2023-03-06	C162847	48780-1	f386c64a-18c8-0266-e053-dadaa90a7c1a	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
70518-1743-0	2023-01-30	C162847	48780-1	f386c64a-18c8-0266-e053-dadaa90a7c1a	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Northwind Health Company, LLC	ab6f50a5-87ce-0819-e053-2a95a90a22b7	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077714 application number: ANDA077714
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	b43e4644-024c-4aa6-b403-19152c785802	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077714 application number: ANDA077714
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2df111dc-ecac-4161-9e22-38436eb37c1f	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077714 application number: ANDA077714
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Bryant Ranch Prepack	17e976c6-ee44-42c5-987f-5360ee6d7c1e	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077714 application number: ANDA077714
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	715cae3e-4e86-48b3-e053-2a95a90afdc2	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077714 application number: ANDA077714
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Bryant Ranch Prepack	e2ecf7a5-1c84-4977-8a87-d1bfb9658668	2024-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077714 application number: ANDA077714
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Bryant Ranch Prepack	facaea7f-cb4d-410f-85e4-e1ac9ff565ac	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077714 application number: ANDA077714
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Breckenridge Pharmaceutical, Inc.	c3832113-f517-4b4e-bf9c-31fce1a638e1	2023-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077714 application number: ANDA077714
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	A-S Medication Solutions	6605103b-fd71-4438-8496-f48973b98901	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077714 application number: ANDA077714
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Proficient Rx LP	4e515f99-7fc7-4692-9105-8e87c27d4e79	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077714 application number: ANDA077714
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	808dab18-43f1-4895-a023-edbde722863e	2017-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077714 application number: ANDA077714

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
70518-1743-0	70518174300	30 TABLET in 1 BLISTER PACK (70518-1743-0)	30 tablet	2018-12-18	0000-00-00	No	No	Current