Terbinafine Hydrochloride

Product NDC
43063-598
11-digit product format
430630598
Labeler code
43063
Product ID
43063-598_cb07e62a-277f-570c-e053-2995a90a7dce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077137
Marketing category
ANDA
Marketing start
2014-08-13
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Allylamine [CS],Allylamine Antifungal [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-598-42EA - Each43063-5985a02672b-5658-48cc-adf0-c144879a1f1412015-10-02
43063-598-90EA - Each43063-5982a35cf8d-2f51-417e-a337-921494c8ddcc12017-07-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-598-424306305984242 TABLET in 1 BOTTLE, PLASTIC (43063-598-42) 42 tablet2020-10-120000-00-00NoNoCurrent
43063-598-904306305989090 TABLET in 1 BOTTLE, PLASTIC (43063-598-90) 90 tablet2020-10-120000-00-00NoNoCurrent