Terbinafine Hydrochloride

Product NDC: 71335-0257
11-digit product format: 713350257
Labeler code: 71335
Product ID: 71335-0257_e1c0429c-36b3-4dad-81e0-0b53655aadc6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Terbinafine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
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 Antifungal [EPC], Allylamine [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-0257		I	Inactivated by FDA	2026-08-17
excluded package	package	71335-0257	71335-0257-1	I	Inactivated by FDA	2026-08-17
excluded package	package	71335-0257	71335-0257-2	I	Inactivated by FDA	2026-08-17
excluded package	package	71335-0257	71335-0257-3	I	Inactivated by FDA	2026-08-17
excluded package	package	71335-0257	71335-0257-4	I	Inactivated by FDA	2026-08-17
excluded package	package	71335-0257	71335-0257-5	I	Inactivated by FDA	2026-08-17
excluded package	package	71335-0257	71335-0257-6	I	Inactivated by FDA	2026-08-17
excluded package	package	71335-0257	71335-0257-7	I	Inactivated by FDA	2026-08-17
excluded package	package	71335-0257	71335-0257-8	I	Inactivated by FDA	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 3 · 135 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0257-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0257-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0257-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0257-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0257-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0257-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0257-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0257-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0257-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0257-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0257-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0257-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0257-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0257-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0257-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0257-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0257-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0257-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0257-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0257-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0257-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0257-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0257-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0257-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0257-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0257-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0257-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0257-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0257-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0257-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0257-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0257-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0257-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0257-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0257-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0257-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0257-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0257-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0257-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0257-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0257-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0257-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0257-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0257-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0257-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0257-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0257-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0257-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0257-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0257-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0257-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0257-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0257-1	`302b2466d912…`	`e7b80fea0513…`

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
71335-0257-1	2024-01-30	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
71335-0257-2	2024-01-30	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
71335-0257-3	2024-01-30	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
71335-0257-4	2024-01-30	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
71335-0257-5	2024-01-30	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
71335-0257-6	2024-01-30	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
71335-0257-7	2024-01-30	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
71335-0257-8	2024-01-30	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
71335-0257-1	2020-02-05	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
71335-0257-2	2020-02-05	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
71335-0257-3	2020-02-05	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
71335-0257-4	2020-02-05	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
71335-0257-5	2020-02-05	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
71335-0257-6	2020-02-05	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
71335-0257-7	2020-02-05	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
71335-0257-8	2020-02-05	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
71335-0257-1	2020-01-31	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
71335-0257-2	2020-01-31	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
71335-0257-3	2020-01-31	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
71335-0257-4	2020-01-31	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
71335-0257-5	2020-01-31	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
71335-0257-6	2020-01-31	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
71335-0257-7	2020-01-31	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
71335-0257-8	2020-01-31	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0257-1	Terbinafine Hydrochloride	30 in 1 BOTTLE	TABLET	30	4
71335-0257-2	Terbinafine Hydrochloride	60 in 1 BOTTLE	TABLET	60	4
71335-0257-3	Terbinafine Hydrochloride	90 in 1 BOTTLE	TABLET	90	4
71335-0257-4	Terbinafine Hydrochloride	100 in 1 BOTTLE	TABLET	100	4
71335-0257-5	Terbinafine Hydrochloride	7 in 1 BOTTLE	TABLET	7	4
71335-0257-6	Terbinafine Hydrochloride	40 in 1 BOTTLE	TABLET	40	4
71335-0257-7	Terbinafine Hydrochloride	45 in 1 BOTTLE	TABLET	45	4
71335-0257-8	Terbinafine Hydrochloride	14 in 1 BOTTLE	TABLET	14	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0257-1	EA - Each	71335-0257	b77bc17c-5e94-485c-a10a-a65f5714f7c1	1	2018-01-12
71335-0257-2	EA - Each	71335-0257	0b2c6564-e591-4e91-8f19-bbe9575665c3	1	2018-01-12
71335-0257-3	EA - Each	71335-0257	46cc24ed-9494-43ec-aa82-632aaa508d87	1	2018-01-12
71335-0257-4	EA - Each	71335-0257	e54b60e5-f3a4-47cd-ba0c-7acc953a1393	1	2018-01-12
71335-0257-5	EA - Each	71335-0257	570a7a4b-000d-4da7-98f5-721ba3c7575a	1	2018-01-12
71335-0257-6	EA - Each	71335-0257	f41ec794-0ec5-4299-819d-ba921665ae32	1	2018-01-12
71335-0257-7	EA - Each	71335-0257	dc022619-b772-406a-a014-ef22601e8d7e	1	2018-01-12
71335-0257-8	EA - Each	71335-0257	7f861526-b39e-4ba4-a1cc-2c65ed981900	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0257	TERBINAFINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	4	Legacy NDC, 8 package rows	20221206_25ba1266-b7f7-457b-a659-7bdb2eccda5d.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 250 MG Oral Tablet	SCD	25ba1266-b7f7-457b-a659-7bdb2eccda5d	4
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	25ba1266-b7f7-457b-a659-7bdb2eccda5d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0257-1	71335025701	30 TABLET in 1 BOTTLE (71335-0257-1)	30 tablet	2015-06-12	0000-00-00	No	No	Current
71335-0257-2	71335025702	60 TABLET in 1 BOTTLE (71335-0257-2)	60 tablet	2015-06-12	0000-00-00	No	No	Current
71335-0257-3	71335025703	90 TABLET in 1 BOTTLE (71335-0257-3)	90 tablet	2015-06-12	0000-00-00	No	No	Current
71335-0257-4	71335025704	100 TABLET in 1 BOTTLE (71335-0257-4)	100 tablet	2015-06-12	0000-00-00	No	No	Current
71335-0257-5	71335025705	7 TABLET in 1 BOTTLE (71335-0257-5)	7 tablet	2015-06-12	0000-00-00	No	No	Current
71335-0257-6	71335025706	40 TABLET in 1 BOTTLE (71335-0257-6)	40 tablet	2015-06-12	0000-00-00	No	No	Current
71335-0257-7	71335025707	45 TABLET in 1 BOTTLE (71335-0257-7)	45 tablet	2015-06-12	0000-00-00	No	No	Current
71335-0257-8	71335025708	14 TABLET in 1 BOTTLE (71335-0257-8)	14 tablet	2015-06-12	0000-00-00	No	No	Current