FDA.reportPublic FDA data

Terbinafine

Product NDC
65862-079
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

Additional Listing Data#

Finished product
Yes
Brand name base
Terbinafine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERBINAFINE HYDROCHLORIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii012C11ZU6G
Rxcui313222

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-079-01Terbinafine100 in 1 BOTTLETABLET10020
65862-079-30Terbinafine30 in 1 BOTTLETABLET3020
65862-079-99Terbinafine1000 in 1 BOTTLETABLET100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-079-30EA - Each65862-07988d0cfba-3b51-4f2f-94c1-e3e030caddef12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERBINAFINE HYDROCHLORIDEACTIVE INGREDIENT012C11ZU6GTERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]10
TERBINAFINEACTIVE MOIETYG7RIW8S0XPTERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]10
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]10
TERBINAFINE HYDROCHLORIDEACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
TERBINAFINEACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TERBINAFINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-079TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]20Current NDC, Legacy NDC, 3 package rows20240421_6600e2b3-65df-4fc3-8081-d574537d27e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN747fdc13-7c3a-4672-b50c-31c51037bda224
313222terbinafine 250 MG Oral TabletSCD747fdc13-7c3a-4672-b50c-31c51037bda224
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY747fdc13-7c3a-4672-b50c-31c51037bda224
313222terbinafine HCl 250 MG Oral TabletPSN6600e2b3-65df-4fc3-8081-d574537d27e320
313222terbinafine 250 MG Oral TabletSCD6600e2b3-65df-4fc3-8081-d574537d27e320
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY6600e2b3-65df-4fc3-8081-d574537d27e320
313222terbinafine HCl 250 MG Oral TabletPSN5de4c245-7086-453b-b90a-7a1242ec2c0b9
313222terbinafine 250 MG Oral TabletSCD5de4c245-7086-453b-b90a-7a1242ec2c0b9
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY5de4c245-7086-453b-b90a-7a1242ec2c0b9
313222terbinafine HCl 250 MG Oral TabletPSN085e0809-6b7f-447e-976e-8276c29daad67
313222terbinafine 250 MG Oral TabletSCD085e0809-6b7f-447e-976e-8276c29daad67
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY085e0809-6b7f-447e-976e-8276c29daad67
313222terbinafine HCl 250 MG Oral TabletPSN44c6f6e7-e0c0-450e-83ce-1ed4f3efddec5
313222terbinafine HCl 250 MG Oral TabletPSN0a54cc4f-0789-46ce-875f-df759aa95d9c5
313222terbinafine 250 MG Oral TabletSCD0a54cc4f-0789-46ce-875f-df759aa95d9c5
313222terbinafine 250 MG Oral TabletSCD44c6f6e7-e0c0-450e-83ce-1ed4f3efddec5
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY44c6f6e7-e0c0-450e-83ce-1ed4f3efddec5
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY0a54cc4f-0789-46ce-875f-df759aa95d9c5
313222terbinafine HCl 250 MG Oral TabletPSN294bc1af-50e3-4bff-8d48-321e673033ce4
313222terbinafine 250 MG Oral TabletSCD294bc1af-50e3-4bff-8d48-321e673033ce4
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY294bc1af-50e3-4bff-8d48-321e673033ce4
313222terbinafine HCl 250 MG Oral TabletPSNba6874fa-2bd9-482d-9ffc-8674288d304c3
313222terbinafine HCl 250 MG Oral TabletPSN87af930f-493c-590e-e053-2a95a90a804a3
313222terbinafine 250 MG Oral TabletSCDba6874fa-2bd9-482d-9ffc-8674288d304c3
313222terbinafine 250 MG Oral TabletSCD87af930f-493c-590e-e053-2a95a90a804a3
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYba6874fa-2bd9-482d-9ffc-8674288d304c3
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY87af930f-493c-590e-e053-2a95a90a804a3
313222terbinafine HCl 250 MG Oral TabletPSNc7cf55e2-f637-e2d9-e053-2995a90a62702
313222terbinafine 250 MG Oral TabletSCDc7cf55e2-f637-e2d9-e053-2995a90a62702
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYc7cf55e2-f637-e2d9-e053-2995a90a62702
313222terbinafine HCl 250 MG Oral TabletPSNdfb8fc2d-4899-4891-a985-755fbdf1d5251
313222terbinafine HCl 250 MG Oral TabletPSN838c6140-19b6-4c2b-aed7-3065bd67af071
313222terbinafine HCl 250 MG Oral TabletPSN1e1adb03-401a-80b0-e063-6294a90a47a01
313222terbinafine HCl 250 MG Oral TabletPSN4ee1b667-0cf6-46e4-a740-4fc27904d5771
313222terbinafine 250 MG Oral TabletSCD838c6140-19b6-4c2b-aed7-3065bd67af071
313222terbinafine 250 MG Oral TabletSCDdfb8fc2d-4899-4891-a985-755fbdf1d5251
313222terbinafine 250 MG Oral TabletSCD1e1adb03-401a-80b0-e063-6294a90a47a01
313222terbinafine 250 MG Oral TabletSCD4ee1b667-0cf6-46e4-a740-4fc27904d5771
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY838c6140-19b6-4c2b-aed7-3065bd67af071
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY1e1adb03-401a-80b0-e063-6294a90a47a01
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY4ee1b667-0cf6-46e4-a740-4fc27904d5771
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYdfb8fc2d-4899-4891-a985-755fbdf1d5251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-079-0165862007901100 TABLET in 1 BOTTLE (65862-079-01) 100 tablet2007-07-020000-00-00NoNoCurrent
65862-079-306586200793030 TABLET in 1 BOTTLE (65862-079-30) 30 tablet2007-07-020000-00-00NoNoCurrent
65862-079-99658620079991000 TABLET in 1 BOTTLE (65862-079-99) 1000 tablet2007-07-020000-00-00NoNoCurrent