Terbinafine Hydrochloride

Product NDC: 67405-500
Requested package NDC: 67405-500-10
11-digit product format: 674050500
Labeler code: 67405
Product ID: 67405-500_515e977b-373d-412f-a7d2-4210197758a7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Terbinafine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Harris Pharmaceutical, Inc.
Application: ANDA077137
Marketing category: ANDA
Marketing start: 2014-08-13
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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67405-500	67405-500-10	D	Discontinued by firm		2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A077137-001	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
A077137-001	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	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077137-001	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	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077137-001	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	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077137-001	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	A077137-001	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	A077137-001	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	A077137-001	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	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077137-001	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	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077137-001	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
2026-08-18 06:07:40	2026-07	A077137-001	AB	1	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077137-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077137-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077137-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077137-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077137-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077137-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077137-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077137-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077137-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077137-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077137-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077137-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077137-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077137-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077137-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077137-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077137-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077137-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077137-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077137-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077137-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077137-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077137-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077137-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077137-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077137-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077137-001	AB	1	`a50c72e98297…`

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
67405-500-03	2025-12-24	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
67405-500-10	2025-12-24	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
67405-500-03	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
67405-500-10	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67405-500-03	EA - Each	67405-500	df4cf449-eb45-408e-a27b-c430d5bdb4d1	1	2014-10-03
67405-500-10	EA - Each	67405-500	1b97d3f0-8e4d-4de1-92cf-4383302daeeb	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Terbinafine Hydrochloride	ACTIVE INGREDIENT	012C11ZU6G	TERBINAFINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
TERBINAFINE	ACTIVE MOIETY	G7RIW8S0XP	TERBINAFINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TERBINAFINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	TERBINAFINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	TERBINAFINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TERBINAFINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TERBINAFINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TERBINAFINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
Terbinafine Hydrochloride	ACTIVE INGREDIENT	012C11ZU6G	TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.]	1
Terbinafine Hydrochloride	ACTIVE INGREDIENT	012C11ZU6G	TERBINAFINE HYDROCHLORIDE TABLET [DIRECTRX]	1
TERBINAFINE	ACTIVE MOIETY	G7RIW8S0XP	TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.]	1
TERBINAFINE	ACTIVE MOIETY	G7RIW8S0XP	TERBINAFINE HYDROCHLORIDE TABLET [DIRECTRX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TERBINAFINE HYDROCHLORIDE TABLET [DIRECTRX]	1
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.]	1
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	TERBINAFINE HYDROCHLORIDE TABLET [DIRECTRX]	1
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	TERBINAFINE HYDROCHLORIDE TABLET [DIRECTRX]	1
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TERBINAFINE HYDROCHLORIDE TABLET [DIRECTRX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TERBINAFINE HYDROCHLORIDE TABLET [DIRECTRX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TERBINAFINE HYDROCHLORIDE TABLET [DIRECTRX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67405-500	TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.]	3	Legacy NDC	20190913_caf80893-b509-408e-8824-d911c5dc83e6.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TERBINAFINE HYDROCHLORIDE	TERBINAFINE TABLETS 250 MG	NuCare Pharmaceuticals,Inc.	bf020c17-578f-74c4-e053-2995a90a9e7d	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077137 application number: ANDA077137
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5d01fde5-e4cf-6670-e053-2991aa0a5b15	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077137 application number: ANDA077137
TERBINAFINE HYDROCHLORIDE	TERBINAFINE TABLETS 250 MG	Cipla USA Inc.	daf41866-6f2b-4483-b575-456becd6e85f	2021-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077137 application number: ANDA077137

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	25ba1266-b7f7-457b-a659-7bdb2eccda5d	4
313222	terbinafine HCl 250 MG Oral Tablet	PSN	5d01fde5-e4cf-6670-e053-2991aa0a5b15	4
313222	terbinafine 250 MG Oral Tablet	SCD	25ba1266-b7f7-457b-a659-7bdb2eccda5d	4
313222	terbinafine 250 MG Oral Tablet	SCD	5d01fde5-e4cf-6670-e053-2991aa0a5b15	4
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	25ba1266-b7f7-457b-a659-7bdb2eccda5d	4
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	5d01fde5-e4cf-6670-e053-2991aa0a5b15	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67405-500-10	67405050010	100 TABLET in 1 BOTTLE (67405-500-10)	100 tablet	2014-08-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc. \| NuCare Pharamaceuticals,Inc.	2024-07-15	HUMAN PRESCRIPTION DRUG LABEL	4
Terbinafine Hydrochloride	Bryant Ranch Prepack	2022-11-30	HUMAN PRESCRIPTION DRUG LABEL	4
Terbinafine Hydrochloride	Bryant Ranch Prepack	2021-12-23	HUMAN PRESCRIPTION DRUG LABEL	2
Terbinafine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	2021-09-02	HUMAN PRESCRIPTION DRUG LABEL	10
TERBINAFINE HYDROCHLORIDE	DirectRX	2020-05-28	HUMAN PRESCRIPTION DRUG LABEL	2
Terbinafine Hydrochloride	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	4
Terbinafine Hydrochloride	Harris Pharmaceutical, Inc. \| Cipla, Ltd.-Goa \| Cipla Kurkumbh	2019-09-12	HUMAN PRESCRIPTION DRUG LABEL	3