terbinafine hydrochloride

Product NDC: 69452-351
11-digit product format: 694520351
Labeler code: 69452
Product ID: 69452-351_233cb04d-09cc-4312-923f-f4666bdf9754
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: terbinafine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA078163
Marketing category: ANDA
Marketing start: 2022-01-28
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
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 · 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078163-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078163-001	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
34221c17-0d8c-4b56-8af3-c74efab4599e	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	Strength	SPL version
69452-351-13	terbinafine hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30		3
69452-351-20	terbinafine hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-351-13	EA - Each	69452-351	ce0630f4-76e4-4fa9-9f93-ebc2d03ba162	1	2022-06-06
69452-351-20	EA - Each	69452-351	317ead21-4e73-42cd-aeba-2b781251f1c7	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-351	TERBINAFINE HYDROCHLORIDE TABLET [BIONPHARMA INC.]	3	Current NDC, Legacy NDC, 2 package rows	20241220_34221c17-0d8c-4b56-8af3-c74efab4599e.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
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 ndc (product): 69452-351
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	5a921005-304e-4f5b-b9ba-681749e2499b	104
313222	terbinafine 250 MG Oral Tablet	SCD	5a921005-304e-4f5b-b9ba-681749e2499b	104
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	5a921005-304e-4f5b-b9ba-681749e2499b	104
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
313222	terbinafine HCl 250 MG Oral Tablet	PSN	34221c17-0d8c-4b56-8af3-c74efab4599e	3
313222	terbinafine 250 MG Oral Tablet	SCD	34221c17-0d8c-4b56-8af3-c74efab4599e	3
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	34221c17-0d8c-4b56-8af3-c74efab4599e	3
313222	terbinafine HCl 250 MG Oral Tablet	PSN	53235270-6ffb-44c8-aa55-debf59e1d964	2
313222	terbinafine 250 MG Oral Tablet	SCD	53235270-6ffb-44c8-aa55-debf59e1d964	2
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	53235270-6ffb-44c8-aa55-debf59e1d964	2
313222	terbinafine HCl 250 MG Oral Tablet	PSN	8f6d7b1a-5a01-4cc5-b5b7-c126ae889557	1
313222	terbinafine 250 MG Oral Tablet	SCD	8f6d7b1a-5a01-4cc5-b5b7-c126ae889557	1
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	8f6d7b1a-5a01-4cc5-b5b7-c126ae889557	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69452-351-13	69452035113	30 TABLET in 1 BOTTLE, PLASTIC (69452-351-13)	30 tablet	2022-01-28	0000-00-00	No	No	Current
69452-351-20	69452035120	100 TABLET in 1 BOTTLE, PLASTIC (69452-351-20)	100 tablet	2022-01-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
terbinafine hydrochloride	REMEDYREPACK INC.	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	7
terbinafine hydrochloride	Proficient Rx LP	2025-09-01	HUMAN PRESCRIPTION DRUG LABEL	2
terbinafine hydrochloride	Bryant Ranch Prepack	2025-02-03	HUMAN PRESCRIPTION DRUG LABEL	104
terbinafine hydrochloride	Bionpharma Inc. \| OrBion Pharmaceuticals Private Limited	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	3
terbinafine hydrochloride	A-S Medication Solutions	2024-10-14	HUMAN PRESCRIPTION DRUG LABEL	1