NAFTIFINE HYDROCHLORIDE

Product NDC
0115-1512
11-digit product format
001151512
Labeler code
0115
Product ID
0115-1512_6cf7b001-6ec3-4d9d-a6b0-7231ecbf3c2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAFTIFINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA206960
Marketing category
ANDA
Marketing start
2017-05-10
Marketing end
0000-00-00
Substance
NAFTIFINE HYDROCHLORIDE
Active strength
20 mg/g
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
0115-1512-46GM - Gram0115-15128b9e102f-fcbc-4e48-a224-3e1119ab8d2012017-06-15
0115-1512-58GM - Gram0115-1512f66fe560-b7cf-4ad2-8631-02bae55aa96612017-06-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1512-45001151512451 TUBE in 1 CARTON (0115-1512-45) > 30 g in 1 TUBE1 tube2017-05-100000-00-00NoNoCurrent
0115-1512-46001151512461 TUBE in 1 CARTON (0115-1512-46) > 45 g in 1 TUBE1 tube2017-05-100000-00-00NoNoCurrent
0115-1512-58001151512581 TUBE in 1 CARTON (0115-1512-58) > 60 g in 1 TUBE1 tube2017-05-100000-00-00NoNoCurrent