TERBINAFINE HYDROCHLORIDE

Product NDC
55648-743
11-digit product format
556480743
Labeler code
55648
Product ID
55648-743_dfe33d51-4932-412a-a90f-47007dc507cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TERBINAFINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA078229
Marketing category
ANDA
Marketing start
2007-07-02
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Allylamine [CS],Allylamine Antifungal [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55648-743IInactivated by FDA2026-10-05
excluded packagepackage55648-74355648-743-01IInactivated by FDA2026-10-05
excluded packagepackage55648-74355648-743-02IInactivated by FDA2026-10-05
excluded packagepackage55648-74355648-743-03IInactivated by FDA2026-10-05
excluded packagepackage55648-74355648-743-05IInactivated by FDA2026-10-05

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 2 · 105 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 packagepackage55648-743-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-743-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-743-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-743-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-743-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-743-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-743-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-743-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-743-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-743-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-743-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-743-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-743-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-743-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-743-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-743-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-743-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-743-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-743-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-743-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-743-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-743-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-743-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-743-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-743-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-743-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-743-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-743-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-743-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-743-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-743-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-743-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-743-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-743-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-743-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-743-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-743-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-743-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-743-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-743-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-743-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-743-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-743-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-743-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-743-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-743-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-743-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-743-02557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078229-001TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-0284e616aacf4f…
2026-08-18 06:07:402026-07A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-023f01610625f2…
2019-09-15 20:21 UTC2019-09A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078229-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2007-07-02f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-743-01TERBINAFINE HYDROCHLORIDE30 in 1 BOTTLETABLET301
55648-743-02TERBINAFINE HYDROCHLORIDE1000 in 1 BOTTLETABLET10001
55648-743-03TERBINAFINE HYDROCHLORIDE100 in 1 BOTTLETABLET1001
55648-743-05TERBINAFINE HYDROCHLORIDE30 in 1 BLISTER PACKTABLET301
55648-743-05TERBINAFINE HYDROCHLORIDE1 in 1 CARTONTABLET11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERBINAFINE HYDROCHLORIDEACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1
TERBINAFINEACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-743TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT LIMITED]1Legacy NDC, 5 package rows20120911_60452f7e-f971-428b-aa6a-9e2c15480bf3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN60452f7e-f971-428b-aa6a-9e2c15480bf31
313222terbinafine 250 MG Oral TabletSCD60452f7e-f971-428b-aa6a-9e2c15480bf31
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY60452f7e-f971-428b-aa6a-9e2c15480bf31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-743-015564807430130 in 1 BOTTLEHistorical
55648-743-02556480743021000 in 1 BOTTLEHistorical
55648-743-0355648074303100 in 1 BOTTLEHistorical
55648-743-055564807430530 in 1 BLISTER PACKHistorical