Terbinafine Hydrochloride

Product NDC: 50090-1048
11-digit product format: 500901048
Labeler code: 50090
Product ID: 50090-1048_1d9dab8d-1e3b-4c35-847d-57dbaa8c2ead
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Terbinafine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA077714
Marketing category: ANDA
Marketing start: 2010-12-27
Substance: TERBINAFINE HYDROCHLORIDE
Active strength: 250 mg/1
Pharmacologic classes: Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Terbinafine Hydrochloride
Listing expiration: 2026-12-31

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
6605103b-fd71-4438-8496-f48973b98901	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-1048-0	2023-02-06	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
50090-1048-1	2023-02-06	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
50090-1048-0	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
50090-1048-1	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1048-0	Terbinafine Hydrochloride	30 in 1 BOTTLE	TABLET	30		15
50090-1048-1	Terbinafine Hydrochloride	90 in 1 BOTTLE	TABLET	90		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1048-0	EA - Each	50090-1048	453bc0bf-7418-4b1b-8a40-fd67314b437b	1	2018-11-06
50090-1048-1	EA - Each	50090-1048	ebf26575-438a-4120-8042-074d4a7badf4	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1048	TERBINAFINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]	15	Current NDC, Legacy NDC, 2 package rows	20231101_6605103b-fd71-4438-8496-f48973b98901.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 · 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 ndc (product): 50090-1048
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313222	terbinafine HCl 250 MG Oral Tablet	PSN	6605103b-fd71-4438-8496-f48973b98901	15
313222	terbinafine 250 MG Oral Tablet	SCD	6605103b-fd71-4438-8496-f48973b98901	15
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	6605103b-fd71-4438-8496-f48973b98901	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1048-0	50090104800	30 TABLET in 1 BOTTLE (50090-1048-0)	30 tablet	2014-11-28	0000-00-00	No	No	Current
50090-1048-1	50090104801	90 TABLET in 1 BOTTLE (50090-1048-1)	90 tablet	2014-11-28	0000-00-00	No	No	Current