terbinafine hydrochloride

Product NDC: 70518-3907
Requested package NDC: 70518-3907-1
11-digit product format: 705183907
Labeler code: 70518
Product ID: 70518-3907_4d26c515-0886-5b32-e063-6294a90a9ebb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: terbinafine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA078163
Marketing category: ANDA
Marketing start: 2023-11-03
Substance: TERBINAFINE HYDROCHLORIDE
Active strength: 250 mg/1
Pharmacologic classes: Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3907	70518-3907-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-3907	70518-3907-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A078163-001	TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		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
A078163-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078163-001	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	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	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	A078163-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078163-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078163-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078163-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078163-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078163-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078163-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078163-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078163-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078163-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078163-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078163-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078163-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078163-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078163-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078163-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078163-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078163-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078163-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078163-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078163-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078163-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078163-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078163-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078163-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078163-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078163-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078163-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078163-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078163-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078163-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078163-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078163-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078163-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078163-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078163-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078163-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078163-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078163-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078163-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: terbinafine hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TERBINAFINE HYDROCHLORIDE	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
012C11ZU6G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313222	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2886b2ff-815f-4621-bc28-1fea082c1920	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
55a24767-1759-5f6a-8888-ea4aa0adac21	Product name	1	20140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-3907-0	terbinafine hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET	90	6
70518-3907-1	terbinafine hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30	6
70518-3907-2	terbinafine hydrochloride	45 in 1 BOTTLE, PLASTIC	TABLET	45	6
70518-3907-3	terbinafine hydrochloride	30 in 1 BLISTER PACK	TABLET	30	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3907	TERBINAFINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]	4	Current NDC, 4 package rows	20240510_2886b2ff-815f-4621-bc28-1fea082c1920.zip

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
terbinafine hydrochloride	TERBINAFINE HYDROCHLORIDE	REMEDYREPACK INC.	2886b2ff-815f-4621-bc28-1fea082c1920	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078163 application number: ANDA078163 ndc (package): 70518-3907-1 ndc (product): 70518-3907 ndc11 (package): 70518390701
terbinafine hydrochloride	TERBINAFINE HYDROCHLORIDE	Proficient Rx LP	53235270-6ffb-44c8-aa55-debf59e1d964	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078163 application number: ANDA078163
terbinafine hydrochloride	TERBINAFINE HYDROCHLORIDE	Bryant Ranch Prepack	5a921005-304e-4f5b-b9ba-681749e2499b	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078163 application number: ANDA078163
terbinafine hydrochloride	TERBINAFINE HYDROCHLORIDE	Bionpharma Inc.	34221c17-0d8c-4b56-8af3-c74efab4599e	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078163 application number: ANDA078163
terbinafine hydrochloride	TERBINAFINE HYDROCHLORIDE	A-S Medication Solutions	8f6d7b1a-5a01-4cc5-b5b7-c126ae889557	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078163 application number: ANDA078163

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313222	terbinafine HCl 250 MG Oral Tablet	PSN	2886b2ff-815f-4621-bc28-1fea082c1920	6
313222	terbinafine 250 MG Oral Tablet	SCD	2886b2ff-815f-4621-bc28-1fea082c1920	6
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	2886b2ff-815f-4621-bc28-1fea082c1920	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
70518-3907-1	70518390701	30 TABLET in 1 BOTTLE, PLASTIC (70518-3907-1)	30 tablet	2023-11-05	0	Current