Tavaborole

Product NDC
69238-1657
11-digit product format
692381657
Labeler code
69238
Product ID
69238-1657_3a89e994-c11b-4867-a1a0-a4e97767fe2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tavaborole
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA212256
Marketing category
ANDA
Marketing start
2020-11-28
Marketing end
0000-00-00
Substance
TAVABOROLE
Active strength
44 mg/mL
Pharmacologic classes
Oxaborole Antifungal [EPC],Protein Synthesis Inhibitors [MoA],Boron Compounds [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1657-4ML - Milliliter69238-165792e0f5be-f42e-4c6d-a896-ef9f6f5e501a12021-03-02
69238-1657-6ML - Milliliter69238-165761bd74fb-0aee-43f7-b99f-dc0d871aac6512021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1657TAVABOROLE SOLUTION [AMNEAL PHARMACEUTICALS NY LLC]7Legacy NDC20230608_c7f19812-3811-4a3a-9909-43a7a7f134d4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-1657-4692381657041 BOTTLE, WITH APPLICATOR in 1 CARTON (69238-1657-4) > 4 mL in 1 BOTTLE, WITH APPLICATOR2020-11-280000-00-00NoNoCurrent
69238-1657-6692381657061 BOTTLE, WITH APPLICATOR in 1 CARTON (69238-1657-6) > 10 mL in 1 BOTTLE, WITH APPLICATOR2020-11-280000-00-00NoNoCurrent