NAFTIFINE HYDROCHLORIDE

Product NDC
0115-1510
11-digit product format
001151510
Labeler code
0115
Product ID
0115-1510_eaabbf9e-b49d-4d23-bd49-8bc5aaee3967
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAFTIFINE HYDROCHLORIDE
Dosage form
GEL
Route
TOPICAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA206165
Marketing category
ANDA
Marketing start
2019-03-20
Marketing end
0000-00-00
Substance
NAFTIFINE HYDROCHLORIDE
Active strength
10 mg/g
Pharmacologic classes
Allylamine [CS],Allylamine Antifungal [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1510-48GM - Gram0115-15107f7419c9-19a1-43fc-8395-3ca04f0bea4012019-06-19
0115-1510-58GM - Gram0115-15109cef488f-2298-4fee-8bfe-a651681a887412019-06-19
0115-1510-63GM - Gram0115-15101136483c-5d7f-470c-bdc6-96cd700b7c1d12019-06-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1510-48001151510481 TUBE in 1 CARTON (0115-1510-48) > 90 g in 1 TUBE1 tube2019-03-200000-00-00NoNoCurrent
0115-1510-58001151510581 TUBE in 1 CARTON (0115-1510-58) > 60 g in 1 TUBE1 tube2019-03-200000-00-00NoNoCurrent
0115-1510-63001151510631 TUBE in 1 CARTON (0115-1510-63) > 40 g in 1 TUBE1 tube2019-03-200000-00-00NoNoCurrent