Acyclovir

Product NDC
0378-8700
11-digit product format
003788700
Labeler code
0378
Product ID
0378-8700_30e195ea-26e4-4747-9e7e-b85e0f6f68d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA202459
Marketing category
ANDA
Marketing start
2013-04-03
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
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
0378-8700-06GM - Gram0378-87004c8fa599-2851-483a-960a-0d27ef49b4af12013-05-02
0378-8700-49GM - Gram0378-8700537cbb9f-9ad5-4bc0-896e-77c56e6ab2ec12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR OINTMENT [MYLAN PHARMACEUTICALS INC.]5
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR OINTMENT [MYLAN PHARMACEUTICALS INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACYCLOVIR OINTMENT [MYLAN PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-8700ACYCLOVIR OINTMENT [MYLAN PHARMACEUTICALS INC.]12Legacy NDC20250101_ce3d5e8b-9401-40be-8ce7-4ea42113f4ab.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-8700-06003788700061 TUBE in 1 CARTON (0378-8700-06) > 15 g in 1 TUBE1 tube2013-04-030000-00-00NoNoCurrent
0378-8700-49003788700491 TUBE in 1 CARTON (0378-8700-49) > 30 g in 1 TUBE1 tube2013-04-030000-00-00NoNoCurrent