Terbinafine

Product NDC: 65862-079
Requested package NDC: 65862-079-39
11-digit product format: 658620079
Labeler code: 65862
Product ID: 65862-079_8f6e6ae9-4903-4823-b788-de387e8c6fb2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Terbinafine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA078297
Marketing category: ANDA
Marketing start: 2007-07-02
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	65862-079	65862-079-39	UNFINISHED	Active or certified unfinished drug listing		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 · 21 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
6600e2b3-65df-4fc3-8081-d574537d27e3	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	SPL version
65862-079-01	Terbinafine	100 in 1 BOTTLE	TABLET	100	20
65862-079-30	Terbinafine	30 in 1 BOTTLE	TABLET	30	20
65862-079-99	Terbinafine	1000 in 1 BOTTLE	TABLET	1000	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-079-30	EA - Each	65862-079	88d0cfba-3b51-4f2f-94c1-e3e030caddef	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TERBINAFINE HYDROCHLORIDE	ACTIVE INGREDIENT	012C11ZU6G	TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	10
TERBINAFINE	ACTIVE MOIETY	G7RIW8S0XP	TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	10
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	10
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	10
TERBINAFINE HYDROCHLORIDE	ACTIVE INGREDIENT	012C11ZU6G	TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
TERBINAFINE	ACTIVE MOIETY	G7RIW8S0XP	TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-079	TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	20	Current NDC, Legacy NDC, 3 package rows	20240421_6600e2b3-65df-4fc3-8081-d574537d27e3.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
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 ndc (product): 65862-079
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313222	terbinafine HCl 250 MG Oral Tablet	PSN	747fdc13-7c3a-4672-b50c-31c51037bda2	24
313222	terbinafine 250 MG Oral Tablet	SCD	747fdc13-7c3a-4672-b50c-31c51037bda2	24
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	747fdc13-7c3a-4672-b50c-31c51037bda2	24
313222	terbinafine HCl 250 MG Oral Tablet	PSN	6600e2b3-65df-4fc3-8081-d574537d27e3	20
313222	terbinafine 250 MG Oral Tablet	SCD	6600e2b3-65df-4fc3-8081-d574537d27e3	20
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	6600e2b3-65df-4fc3-8081-d574537d27e3	20
313222	terbinafine HCl 250 MG Oral Tablet	PSN	5de4c245-7086-453b-b90a-7a1242ec2c0b	9
313222	terbinafine 250 MG Oral Tablet	SCD	5de4c245-7086-453b-b90a-7a1242ec2c0b	9
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	5de4c245-7086-453b-b90a-7a1242ec2c0b	9
313222	terbinafine HCl 250 MG Oral Tablet	PSN	085e0809-6b7f-447e-976e-8276c29daad6	7
313222	terbinafine 250 MG Oral Tablet	SCD	085e0809-6b7f-447e-976e-8276c29daad6	7
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	085e0809-6b7f-447e-976e-8276c29daad6	7
313222	terbinafine HCl 250 MG Oral Tablet	PSN	44c6f6e7-e0c0-450e-83ce-1ed4f3efddec	5
313222	terbinafine HCl 250 MG Oral Tablet	PSN	0a54cc4f-0789-46ce-875f-df759aa95d9c	5
313222	terbinafine 250 MG Oral Tablet	SCD	0a54cc4f-0789-46ce-875f-df759aa95d9c	5
313222	terbinafine 250 MG Oral Tablet	SCD	44c6f6e7-e0c0-450e-83ce-1ed4f3efddec	5
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	44c6f6e7-e0c0-450e-83ce-1ed4f3efddec	5
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	0a54cc4f-0789-46ce-875f-df759aa95d9c	5
313222	terbinafine HCl 250 MG Oral Tablet	PSN	294bc1af-50e3-4bff-8d48-321e673033ce	4
313222	terbinafine 250 MG Oral Tablet	SCD	294bc1af-50e3-4bff-8d48-321e673033ce	4
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	294bc1af-50e3-4bff-8d48-321e673033ce	4
313222	terbinafine HCl 250 MG Oral Tablet	PSN	ba6874fa-2bd9-482d-9ffc-8674288d304c	3
313222	terbinafine HCl 250 MG Oral Tablet	PSN	87af930f-493c-590e-e053-2a95a90a804a	3
313222	terbinafine 250 MG Oral Tablet	SCD	ba6874fa-2bd9-482d-9ffc-8674288d304c	3
313222	terbinafine 250 MG Oral Tablet	SCD	87af930f-493c-590e-e053-2a95a90a804a	3
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	ba6874fa-2bd9-482d-9ffc-8674288d304c	3
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	87af930f-493c-590e-e053-2a95a90a804a	3
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
313222	terbinafine HCl 250 MG Oral Tablet	PSN	dfb8fc2d-4899-4891-a985-755fbdf1d525	1
313222	terbinafine HCl 250 MG Oral Tablet	PSN	838c6140-19b6-4c2b-aed7-3065bd67af07	1
313222	terbinafine HCl 250 MG Oral Tablet	PSN	1e1adb03-401a-80b0-e063-6294a90a47a0	1
313222	terbinafine HCl 250 MG Oral Tablet	PSN	4ee1b667-0cf6-46e4-a740-4fc27904d577	1
313222	terbinafine 250 MG Oral Tablet	SCD	838c6140-19b6-4c2b-aed7-3065bd67af07	1
313222	terbinafine 250 MG Oral Tablet	SCD	dfb8fc2d-4899-4891-a985-755fbdf1d525	1
313222	terbinafine 250 MG Oral Tablet	SCD	1e1adb03-401a-80b0-e063-6294a90a47a0	1
313222	terbinafine 250 MG Oral Tablet	SCD	4ee1b667-0cf6-46e4-a740-4fc27904d577	1
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	838c6140-19b6-4c2b-aed7-3065bd67af07	1
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	1e1adb03-401a-80b0-e063-6294a90a47a0	1
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	4ee1b667-0cf6-46e4-a740-4fc27904d577	1
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	dfb8fc2d-4899-4891-a985-755fbdf1d525	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
65862-079-39	65862007939	3000 TABLET in 1 BAG (65862-079-39)	3000 tablet	02-JUL-07	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Terbinafine	American Health Packaging	2026-03-06	HUMAN PRESCRIPTION DRUG LABEL	1
Terbinafine	REMEDYREPACK INC.	2026-02-13	HUMAN PRESCRIPTION DRUG LABEL	5
Terbinafine	A-S Medication Solutions	2025-12-18	Human Prescription Drug Label	9
Terbinafine	PD-Rx Pharmaceuticals, Inc.	2025-10-14	HUMAN PRESCRIPTION DRUG LABEL	24
Terbinafine	Preferred Pharmaceuticals, Inc.	2025-09-30	HUMAN PRESCRIPTION DRUG LABEL	7
Terbinafine	Bryant Ranch Prepack	2025-09-18	HUMAN PRESCRIPTION DRUG LABEL	1
TERBINAFINE	direct rx	2025-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
Terbinafine	Proficient Rx LP	2024-09-01	HUMAN PRESCRIPTION DRUG LABEL	5
Terbinafine	RedPharm Drug	2024-07-25	HUMAN PRESCRIPTION DRUG LABEL	1
Terbinafine	NuCare Pharmaceuticals,Inc.	2024-06-14	HUMAN PRESCRIPTION DRUG LABEL	3
Terbinafine	Bryant Ranch Prepack	2024-05-30	HUMAN PRESCRIPTION DRUG LABEL	4
Terbinafine	Aurobindo Pharma Limited	2024-04-18	Human Prescription Drug Label	20
Terbinafine	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	3
Terbinafine	Lake Erie Medical DBA Quality Care Products LLC	2021-04-15	Human Prescription Drug Label	3
Terbinafine	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	2
Terbinafine Hydrochloride Tablets	Rebel Distributors Corp	2011-02-09	HUMAN PRESCRIPTION DRUG LABEL	1