Acyclovir

Product NDC
68788-0715
11-digit product format
687880715
Labeler code
68788
Product ID
68788-0715_f1d500d6-fbe8-4454-b365-53d5ef591795
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc
Application
ANDA077026
Marketing category
ANDA
Marketing start
2011-03-18
Marketing end
0000-00-00
Substance
ACYCLOVIR
Active strength
200 mg/5mL
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-0715DDiscontinued by firm2026-07-31
excluded packagepackage68788-071568788-0715-4DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077026-001ACYCLOVIRACYCLOVIR200MG/5MLSUSPENSION / ORAL2005-06-07