Terbinafine

Product NDC: 70518-4323
11-digit product format: 705184323
Labeler code: 70518
Product ID: 70518-4323_316807fa-b484-7ab1-e063-6394a90a7878
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Terbinafine
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA077533
Marketing category: ANDA
Marketing start: 2025-03-28
Marketing end: 2026-09-30
Substance: TERBINAFINE HYDROCHLORIDE
Active strength: 250 mg/1
Pharmacologic classes: Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag: No
Current FDA listing: Yes

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
A077533-001	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 · 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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077533-001	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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077533-001	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	A077533-001	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	A077533-001	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	A077533-001	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	A077533-001	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	A077533-001	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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077533-001	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	A077533-001	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	A077533-001	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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077533-001	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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077533-001	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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077533-001	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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077533-001	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	A077533-001	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	A077533-001	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	A077533-001	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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077533-001	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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077533-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077533-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077533-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077533-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077533-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077533-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077533-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077533-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077533-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077533-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077533-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077533-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077533-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077533-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077533-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077533-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077533-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077533-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077533-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077533-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077533-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077533-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077533-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077533-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077533-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077533-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077533-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077533-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077533-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077533-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077533-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077533-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077533-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077533-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077533-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077533-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077533-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077533-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077533-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077533-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Terbinafine

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
79ddc2e9-ea43-41a2-a5b0-b13b3eaf7d7a	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
70518-4323-0	Terbinafine	30 in 1 BOTTLE, PLASTIC	TABLET	30	1
70518-4323-1	Terbinafine	14 in 1 BOTTLE, PLASTIC	TABLET	14	1
70518-4323-2	Terbinafine	30 in 1 BLISTER PACK	TABLET	30	1

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	TERBINAFINE	REMEDYREPACK INC.	cacf5fe4-8c24-47ed-9a2b-b70aa5d45ef2	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077533 application number: ANDA077533
Terbinafine	TERBINAFINE	Cipla USA Inc.	18b16aad-1877-4b07-b532-f0ef4843af91	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077533 application number: ANDA077533
Terbinafine	TERBINAFINE	REMEDYREPACK INC.	79ddc2e9-ea43-41a2-a5b0-b13b3eaf7d7a	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077533 application number: ANDA077533 ndc (product): 70518-4323
Terbinafine	TERBINAFINE	Exelan Pharmaceuticals Inc.	6dc279cc-9861-4fa8-8083-ca3b3c57b513	2020-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077533 application number: ANDA077533
Terbinafine	TERBINAFINE	Proficient Rx LP	3925dc10-ad66-46a8-bfa5-1a4314be3521	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077533 application number: ANDA077533

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
012C11ZU6G	TERBINAFINE HYDROCHLORIDE	78628-80-5	TERBINAFINE HYDROCHLORIDE
G7RIW8S0XP	TERBINAFINE	91161-71-6	Terbinafine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313222	terbinafine HCl 250 MG Oral Tablet	PSN	79ddc2e9-ea43-41a2-a5b0-b13b3eaf7d7a	1
313222	terbinafine 250 MG Oral Tablet	SCD	79ddc2e9-ea43-41a2-a5b0-b13b3eaf7d7a	1
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	79ddc2e9-ea43-41a2-a5b0-b13b3eaf7d7a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-4323-0	70518432300	30 TABLET in 1 BOTTLE, PLASTIC (70518-4323-0)	30 tablet	2025-03-28	2026-09-30	No	No	Historical
70518-4323-1	70518432301	14 TABLET in 1 BOTTLE, PLASTIC (70518-4323-1)	14 tablet	2025-04-09	2026-09-30	No	No	Historical
70518-4323-2	70518432302	30 TABLET in 1 BLISTER PACK (70518-4323-2)	30 tablet	2025-05-15	2026-09-30	No	No	Historical