Terbinafine Hydrochloride

Product NDC: 63629-1993
11-digit product format: 636291993
Labeler code: 63629
Product ID: 63629-1993_2b858a61-405a-4352-9da9-978bb1f5a29a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Terbinafine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
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

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	63629-1993		D	Discontinued by firm		2026-08-17
excluded package	package	63629-1993	63629-1993-1	D	Discontinued by firm		2026-08-17

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
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 · 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	A077714-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2010-06-04	`caaa826d4ba7…`
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…`

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…`

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	Strength	SPL version
63629-1993-1	Terbinafine Hydrochloride	100 in 1 BOTTLE	TABLET	100		103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1993-1	EA - Each	63629-1993	d8a0d2c5-68a3-475a-9a2c-ff1ada042787	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-1993	TERBINAFINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 1 package rows	20240110_facaea7f-cb4d-410f-85e4-e1ac9ff565ac.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 · 10 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	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313222	terbinafine HCl 250 MG Oral Tablet	PSN	facaea7f-cb4d-410f-85e4-e1ac9ff565ac	103
313222	terbinafine 250 MG Oral Tablet	SCD	facaea7f-cb4d-410f-85e4-e1ac9ff565ac	103
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	facaea7f-cb4d-410f-85e4-e1ac9ff565ac	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1993-1	63629199301	100 TABLET in 1 BOTTLE (63629-1993-1)	100 tablet	2010-12-27	0000-00-00	No	No	Current