Acyclovir

Product NDC
35573-403
11-digit product format
355730403
Labeler code
35573
Product ID
35573-403_f9a626f6-8d1b-4186-a495-4e27d3ea8505
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Burel Pharmaceuticals, LLC
Application
ANDA205591
Marketing category
ANDA
Marketing start
2019-05-09
Marketing end
0000-00-00
Substance
ACYCLOVIR
Active strength
50 mg/g
Pharmacologic classes
DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]
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
35573-403-15GM - Gram35573-403a80d1459-c488-4b1b-ae9b-74979dfab75512019-06-19
35573-403-31GM - Gram35573-40360601a97-a9ee-40a8-818f-54f5d99116fe12019-06-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35573-403-15355730403151 TUBE in 1 CARTON (35573-403-15) > 15 g in 1 TUBE1 tube2019-05-090000-00-00NoNoCurrent
35573-403-31355730403311 TUBE in 1 CARTON (35573-403-31) > 30 g in 1 TUBE1 tube2019-05-090000-00-00NoNoCurrent