FDA.reportPublic FDA data

Terbinafine Hydrochloride

Product NDC
51991-526
11-digit product format
519910526
Labeler code
51991
Product ID
51991-526_1603cd34-5cf4-4130-966f-c156d9237346
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA077714
Marketing category
ANDA
Marketing start
2010-12-27
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 Hydrochloride
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
51991-526-01Terbinafine Hydrochloride100 in 1 BOTTLETABLET10015
51991-526-33Terbinafine Hydrochloride30 in 1 BOTTLETABLET3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-526-01EA - Each51991-526b2b1f78b-4223-47b6-b0e8-1f69adb0ebd412012-07-24
51991-526-33EA - Each51991-526059c04c7-1bfb-49ea-8cd5-e99302326bcb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]5
TerbinafineACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]5
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UTERBINAFINE HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]5
HypromellosesINACTIVE INGREDIENT3NXW29V3WOTERBINAFINE HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]5
Magnesium StearateINACTIVE INGREDIENT70097M6I30TERBINAFINE HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]5
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4TERBINAFINE HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]5
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2TERBINAFINE HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]5
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TerbinafineACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UTERBINAFINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOTERBINAFINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30TERBINAFINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4TERBINAFINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2TERBINAFINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-526TERBINAFINE HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]15Current NDC, Legacy NDC, 2 package rows20240327_c3832113-f517-4b4e-bf9c-31fce1a638e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSNfacaea7f-cb4d-410f-85e4-e1ac9ff565ac103
313222terbinafine 250 MG Oral TabletSCDfacaea7f-cb4d-410f-85e4-e1ac9ff565ac103
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYfacaea7f-cb4d-410f-85e4-e1ac9ff565ac103
313222terbinafine HCl 250 MG Oral TabletPSNe2ecf7a5-1c84-4977-8a87-d1bfb9658668101
313222terbinafine 250 MG Oral TabletSCDe2ecf7a5-1c84-4977-8a87-d1bfb9658668101
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYe2ecf7a5-1c84-4977-8a87-d1bfb9658668101
313222terbinafine HCl 250 MG Oral TabletPSN2df111dc-ecac-4161-9e22-38436eb37c1f20
313222terbinafine 250 MG Oral TabletSCD2df111dc-ecac-4161-9e22-38436eb37c1f20
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY2df111dc-ecac-4161-9e22-38436eb37c1f20
313222terbinafine HCl 250 MG Oral TabletPSNc3832113-f517-4b4e-bf9c-31fce1a638e115
313222terbinafine HCl 250 MG Oral TabletPSN6605103b-fd71-4438-8496-f48973b9890115
313222terbinafine 250 MG Oral TabletSCD6605103b-fd71-4438-8496-f48973b9890115
313222terbinafine 250 MG Oral TabletSCDc3832113-f517-4b4e-bf9c-31fce1a638e115
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY6605103b-fd71-4438-8496-f48973b9890115
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYc3832113-f517-4b4e-bf9c-31fce1a638e115
313222terbinafine HCl 250 MG Oral TabletPSNb43e4644-024c-4aa6-b403-19152c78580210
313222terbinafine 250 MG Oral TabletSCDb43e4644-024c-4aa6-b403-19152c78580210
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYb43e4644-024c-4aa6-b403-19152c78580210
313222terbinafine HCl 250 MG Oral TabletPSN17e976c6-ee44-42c5-987f-5360ee6d7c1e7
313222terbinafine 250 MG Oral TabletSCD17e976c6-ee44-42c5-987f-5360ee6d7c1e7
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY17e976c6-ee44-42c5-987f-5360ee6d7c1e7
313222terbinafine HCl 250 MG Oral TabletPSN4e515f99-7fc7-4692-9105-8e87c27d4e796
313222terbinafine 250 MG Oral TabletSCD4e515f99-7fc7-4692-9105-8e87c27d4e796
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY4e515f99-7fc7-4692-9105-8e87c27d4e796
313222terbinafine HCl 250 MG Oral TabletPSNab6f50a5-87ce-0819-e053-2a95a90a22b75
313222terbinafine HCl 250 MG Oral TabletPSN715cae3e-4e86-48b3-e053-2a95a90afdc25
313222terbinafine 250 MG Oral TabletSCDab6f50a5-87ce-0819-e053-2a95a90a22b75
313222terbinafine 250 MG Oral TabletSCD715cae3e-4e86-48b3-e053-2a95a90afdc25
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYab6f50a5-87ce-0819-e053-2a95a90a22b75
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY715cae3e-4e86-48b3-e053-2a95a90afdc25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-526-0151991052601100 TABLET in 1 BOTTLE (51991-526-01) 100 tablet2010-12-270000-00-00NoNoCurrent
51991-526-335199105263330 TABLET in 1 BOTTLE (51991-526-33) 30 tablet2010-12-270000-00-00NoNoCurrent