Home NDC 43063-589 Acyclovir
Product NDC 43063-589
11-digit product format 430630589
Labeler code 43063
Product ID 43063-589_509f352e-407a-d52b-e063-6294a90a696a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA203834
Marketing category ANDA
Marketing start 2013-11-29
Substance ACYCLOVIR
Active strength 800 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 No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Acyclovir
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACYCLOVIR 800 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii X4HES1O11F Rxcui 197313
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43063-589-10 Acyclovir 10 in 1 BOTTLE, PLASTIC TABLET 10 17 43063-589-30 Acyclovir 30 in 1 BOTTLE, PLASTIC TABLET 30 17 43063-589-35 Acyclovir 35 in 1 BOTTLE, PLASTIC TABLET 35 17 43063-589-50 Acyclovir 50 in 1 BOTTLE, PLASTIC TABLET 50 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACYCLOVIR ACTIVE INGREDIENT X4HES1O11F ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 4 ACYCLOVIR ACTIVE MOIETY X4HES1O11F ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 4 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 4 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 4 POVIDONE INACTIVE INGREDIENT FZ989GH94E ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-589 ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 15 Current NDC, Legacy NDC, 4 package rows 20241013_e8a0f9f8-294f-4dd6-bd55-10a6253f1aa8.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43063-589-10 43063058910 10 TABLET in 1 BOTTLE, PLASTIC (43063-589-10) 10 tablet 2016-08-04 0000-00-00 No No Current 43063-589-30 43063058930 30 TABLET in 1 BOTTLE, PLASTIC (43063-589-30) 30 tablet 2015-09-29 0000-00-00 No No Current 43063-589-35 43063058935 35 TABLET in 1 BOTTLE, PLASTIC (43063-589-35) 35 tablet 2015-08-06 0000-00-00 No No Current 43063-589-50 43063058950 50 TABLET in 1 BOTTLE, PLASTIC (43063-589-50) 50 tablet 2015-09-11 0000-00-00 No No Current