Terbinafine Hydrochloride

Product NDC
70518-0553
11-digit product format
705180553
Labeler code
70518
Product ID
70518-0553_bed8b5fb-b4e0-8ec2-e053-2a95a90a1a4a
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
REMEDYREPACK INC.
Application
ANDA077511
Marketing category
ANDA
Marketing start
2017-05-25
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0553-0705180553001 TUBE in 1 CARTON (70518-0553-0) > 30 g in 1 TUBE1 tube2017-05-250000-00-00NoNoCurrent