FDA.reportPublic FDA data

Terbinafine

Product NDC
68788-7722
11-digit product format
687887722
Labeler code
68788
Product ID
68788-7722_14b441a7-67ea-4a90-bfeb-381bc10362a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA077533
Marketing category
ANDA
Marketing start
2020-07-01
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 1/1
Pharmacologic classes
Allylamine [CS],Allylamine Antifungal [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-7722-12022-01-28C16284748780-1d6a99b39-42f3-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use TERBINAFINE TABLETS safely and effectively. See full prescribing information for TERBINAFINE TABLETS. TERBINAFINE tablets, for oral use Initial U.S. Approval: 1992
68788-7722-32022-01-28C16284748780-1d6a99b39-42f3-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use TERBINAFINE TABLETS safely and effectively. See full prescribing information for TERBINAFINE TABLETS. TERBINAFINE tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7722-1Terbinafine100 in 1 BOTTLETABLET1001
68788-7722-3Terbinafine30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7722-1EA - Each68788-7722c4333ad5-c9a7-4fe1-8155-95ce6906e9d912020-09-14
68788-7722-3EA - Each68788-7722cdd58dd8-94ac-44e4-8748-685d5cc219b612020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7722TERBINAFINE TABLET [PREFERRED PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20200722_14b441a7-67ea-4a90-bfeb-381bc10362a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN14b441a7-67ea-4a90-bfeb-381bc10362a41
313222terbinafine 250 MG Oral TabletSCD14b441a7-67ea-4a90-bfeb-381bc10362a41
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY14b441a7-67ea-4a90-bfeb-381bc10362a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7722-168788772201100 TABLET in 1 BOTTLE (68788-7722-1) 100 tablet2020-07-010000-00-00NoNoCurrent
68788-7722-36878877220330 TABLET in 1 BOTTLE (68788-7722-3) 30 tablet2020-07-010000-00-00NoNoCurrent