Terbinafine Hydrochloride

Product NDC: 68151-1327
11-digit product format: 681511327
Labeler code: 68151
Product ID: 68151-1327_d277a6e5-f60f-4265-998d-6c662617d7b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Terbinafine
Dosage form: TABLET
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA077533
Marketing category: ANDA
Marketing start: 2011-01-01
Marketing end: 0000-00-00
Substance: TERBINAFINE HYDROCHLORIDE
Active strength: 250 1/1
Pharmacologic classes: Allylamine [CS],Allylamine Antifungal [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68151-1327		I	Inactivated by FDA		2026-08-17
excluded package	package	68151-1327	68151-1327-0	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 1 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68151-1327-0	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68151-1327-0	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68151-1327-0	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68151-1327-0	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68151-1327-0	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68151-1327-0	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68151-1327-0	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68151-1327-0	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68151-1327-0	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68151-1327-0	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68151-1327-0	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68151-1327-0	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68151-1327-0	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68151-1327-0	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68151-1327-0	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68151-1327-0	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68151-1327-0	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68151-1327-0	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68151-1327-0	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68151-1327-0	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68151-1327-0	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68151-1327-0	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A077533-001	TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL			2007-07-02

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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077533-001	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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077533-001	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	A077533-001	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	A077533-001	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	A077533-001	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	A077533-001	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	A077533-001	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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077533-001	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	A077533-001	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	A077533-001	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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077533-001	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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077533-001	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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077533-001	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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077533-001	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	A077533-001	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	A077533-001	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	A077533-001	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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077533-001	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	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077533-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077533-001	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
2026-02-19 14:30 UTC	2026-02	A077533-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077533-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077533-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077533-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077533-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077533-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077533-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077533-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077533-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077533-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077533-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077533-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077533-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077533-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077533-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077533-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077533-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077533-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077533-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077533-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077533-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077533-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077533-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077533-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077533-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077533-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077533-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077533-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077533-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077533-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077533-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077533-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077533-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077533-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077533-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077533-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077533-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077533-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077533-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077533-001	AB	1	`cb3db0bc1861…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-1327-0	2020-01-31	C162847	48780-1	9d75b9d0-a08d-f424-e053-dadaa90a57ce	Terbinafine tablets, USP 250 mg for oral use These highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-1327-0	Terbinafine Hydrochloride	1 in 1 PACKAGE	TABLET	1		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TERBINAFINE HYDROCHLORIDE	ACTIVE INGREDIENT	012C11ZU6G	TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT]	2
TERBINAFINE	ACTIVE MOIETY	G7RIW8S0XP	TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-1327	TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT]	2	Legacy NDC, 1 package rows	20140828_984ad737-0cfe-4bee-888d-3a07b23cb7cd.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	TERBINAFINE	REMEDYREPACK INC.	cacf5fe4-8c24-47ed-9a2b-b70aa5d45ef2	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077533 application number: ANDA077533
Terbinafine	TERBINAFINE	Cipla USA Inc.	18b16aad-1877-4b07-b532-f0ef4843af91	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077533 application number: ANDA077533
Terbinafine	TERBINAFINE	REMEDYREPACK INC.	79ddc2e9-ea43-41a2-a5b0-b13b3eaf7d7a	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077533 application number: ANDA077533
Terbinafine	TERBINAFINE	Exelan Pharmaceuticals Inc.	6dc279cc-9861-4fa8-8083-ca3b3c57b513	2020-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077533 application number: ANDA077533
Terbinafine	TERBINAFINE	Proficient Rx LP	3925dc10-ad66-46a8-bfa5-1a4314be3521	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077533 application number: ANDA077533

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	984ad737-0cfe-4bee-888d-3a07b23cb7cd	2
313222	terbinafine 250 MG Oral Tablet	SCD	984ad737-0cfe-4bee-888d-3a07b23cb7cd	2
313222	terbinafine (as terbinafine HCl) 250 MG Oral Tablet	SY	984ad737-0cfe-4bee-888d-3a07b23cb7cd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-1327-0	68151132700	1 in 1 PACKAGE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Terbinafine Hydrochloride	Carilion Materials Management	2012-09-18	HUMAN PRESCRIPTION DRUG LABEL	2