Terbinafine

Product NDC
67405-543
11-digit product format
674050543
Labeler code
67405
Product ID
67405-543_6154aa0a-55b4-478b-9edd-503a96ec0dac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine
Dosage form
TABLET
Route
ORAL
Labeler
HARRIS Pharmaceutical, Inc.
Application
ANDA077919
Marketing category
ANDA
Marketing start
2007-07-30
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 mg/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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67405-543DDiscontinued by firm2026-08-10
excluded packagepackage67405-54367405-543-03DDiscontinued by firm2026-08-10
excluded packagepackage67405-54367405-543-10DDiscontinued by firm2026-08-10

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67405-543-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67405-543-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67405-543-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67405-543-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67405-543-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67405-543-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67405-543-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67405-543-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67405-543-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67405-543-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67405-543-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67405-543-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67405-543-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67405-543-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67405-543-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67405-543-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67405-543-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67405-543-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67405-543-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67405-543-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67405-543-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67405-543-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67405-543-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67405-543-10557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077919-001TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A077919-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-023f01610625f2…
2019-09-15 20:21 UTC2019-09A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077919-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077919-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077919-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077919-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077919-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077919-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077919-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077919-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077919-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077919-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077919-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077919-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077919-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077919-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077919-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077919-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077919-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077919-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077919-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077919-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077919-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077919-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077919-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077919-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077919-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077919-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077919-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077919-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077919-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077919-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077919-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077919-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077919-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077919-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077919-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077919-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077919-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077919-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077919-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077919-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077919-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67405-543-03EA - Each67405-5436b60aa26-d075-4b2a-b5ed-9a510c24d02912012-07-24
67405-543-10EA - Each67405-543c36fe05f-58a6-4ab6-b7b2-251160924f9612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERBINAFINE HYDROCHLORIDEACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC]1
TERBINAFINEACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTERBINAFINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTERBINAFINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERBINAFINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TERBINAFINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TERBINAFINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC]1