Home NDC 52959-517 Acyclovir
Product NDC 52959-517
11-digit product format 529590517
Labeler code 52959
Product ID 52959-517_316f8dac-8a38-4351-819e-9e5d5fc38c50
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form CAPSULE
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application ANDA074578
Marketing category ANDA
Marketing start 2011-05-27
Marketing end 0000-00-00
Substance ACYCLOVIR
Active strength 200 mg/1
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 DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52959-517-25 Acyclovir 25 in 1 BOTTLE CAPSULE 25 1 52959-517-30 Acyclovir 30 in 1 BOTTLE CAPSULE 30 1 52959-517-35 Acyclovir 35 in 1 BOTTLE CAPSULE 35 1 52959-517-50 Acyclovir 50 in 1 BOTTLE CAPSULE 50 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACYCLOVIR ACTIVE INGREDIENT X4HES1O11F ACYCLOVIR CAPSULE [H.J. HARKINS COMPANY, INC.] 1 ACYCLOVIR ACTIVE MOIETY X4HES1O11F ACYCLOVIR CAPSULE [H.J. HARKINS COMPANY, INC.] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH ACYCLOVIR CAPSULE [H.J. HARKINS COMPANY, INC.] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L ACYCLOVIR CAPSULE [H.J. HARKINS COMPANY, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ACYCLOVIR CAPSULE [H.J. HARKINS COMPANY, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ACYCLOVIR CAPSULE [H.J. HARKINS COMPANY, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ACYCLOVIR CAPSULE [H.J. HARKINS COMPANY, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ACYCLOVIR CAPSULE [H.J. HARKINS COMPANY, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L ACYCLOVIR CAPSULE [H.J. HARKINS COMPANY, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ACYCLOVIR CAPSULE [H.J. HARKINS COMPANY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACYCLOVIR CAPSULE [H.J. HARKINS COMPANY, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ACYCLOVIR CAPSULE [H.J. HARKINS COMPANY, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ACYCLOVIR CAPSULE [H.J. HARKINS COMPANY, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACYCLOVIR CAPSULE [H.J. HARKINS COMPANY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-517 ACYCLOVIR CAPSULE [H.J. HARKINS COMPANY, INC.] 1 Legacy NDC, 4 package rows 20111205_2f9d7db0-6dee-47b6-be50-9192204daf4d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 52959-517-25 52959051725 25 in 1 BOTTLE Historical 52959-517-30 52959051730 30 in 1 BOTTLE Historical 52959-517-35 52959051735 35 in 1 BOTTLE Historical 52959-517-50 52959051750 50 in 1 BOTTLE Historical