TERBINAFINE

Product NDC: 72189-243
11-digit product format: 721890243
Labeler code: 72189
Product ID: 72189-243_2c28596f-8fc8-42e5-e063-6294a90a0ad6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TERBINAFINE
Dosage form: TABLET
Route: ORAL
Labeler: direct rx
Application: ANDA078297
Marketing category: ANDA
Marketing start: 2021-07-23
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

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-243-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-243-30	`0efc9e666f02…`	`f202fb6c5f17…`

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
A078297-001	TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	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
A078297-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078297-001	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	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078297-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078297-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078297-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078297-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078297-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078297-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078297-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078297-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078297-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078297-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078297-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078297-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078297-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078297-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078297-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078297-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078297-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078297-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078297-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078297-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078297-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078297-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078297-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078297-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078297-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078297-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078297-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078297-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078297-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078297-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078297-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078297-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078297-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078297-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078297-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078297-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078297-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078297-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078297-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078297-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: TERBINAFINE
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
c7cf55e2-f637-e2d9-e053-2995a90a6270	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
72189-243-30	TERBINAFINE	30 in 1 BOTTLE	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-243-30	EA - Each	72189-243	527cd2ce-29c8-4f66-86b0-d09b7a13170c	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-243	TERBINAFINE TABLET [DIRECT RX]	2	Current NDC, Legacy NDC, 1 package rows	20250121_c7cf55e2-f637-e2d9-e053-2995a90a6270.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terbinafine	TERBINAFINE HYDROCHLORIDE	American Health Packaging	4ee1b667-0cf6-46e4-a740-4fc27904d577	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	REMEDYREPACK INC.	44c6f6e7-e0c0-450e-83ce-1ed4f3efddec	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	A-S Medication Solutions	5de4c245-7086-453b-b90a-7a1242ec2c0b	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	747fdc13-7c3a-4672-b50c-31c51037bda2	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	085e0809-6b7f-447e-976e-8276c29daad6	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	Bryant Ranch Prepack	838c6140-19b6-4c2b-aed7-3065bd67af07	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
TERBINAFINE	TERBINAFINE	direct rx	c7cf55e2-f637-e2d9-e053-2995a90a6270	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297 ndc (product): 72189-243
Terbinafine	TERBINAFINE HYDROCHLORIDE	Proficient Rx LP	0a54cc4f-0789-46ce-875f-df759aa95d9c	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	87af930f-493c-590e-e053-2a95a90a804a	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	Bryant Ranch Prepack	294bc1af-50e3-4bff-8d48-321e673033ce	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	A-S Medication Solutions	79a39fb1-12b7-4b1e-9f28-102af34d0459	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	Aurobindo Pharma Limited	6600e2b3-65df-4fc3-8081-d574537d27e3	2024-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	NorthStar Rx LLC	8f87e3e1-4c9c-497a-af20-8ab52cfeef60	2024-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	Proficient Rx LP	50657431-1cd9-42dd-9cfc-57db8713d267	2024-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297

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	c7cf55e2-f637-e2d9-e053-2995a90a6270	2
313222	terbinafine 250 MG Oral Tablet	SCD	c7cf55e2-f637-e2d9-e053-2995a90a6270	2
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	c7cf55e2-f637-e2d9-e053-2995a90a6270	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-243-30	72189024330	30 TABLET in 1 BOTTLE (72189-243-30)	30 tablet	2021-07-23	0000-00-00	No	No	Current