Acyclovir

Product NDC
50383-810
11-digit product format
503830810
Labeler code
50383
Product ID
50383-810_b47fc4d7-9705-491c-8ee3-8402517620cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
SUSPENSION
Route
ORAL
Labeler
Akorn
Application
ANDA077026
Marketing category
ANDA
Marketing start
2005-06-07
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
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33190c02-82e1-0a4d-d716-9ccd23588463Product name520250225
c367d1da-5a72-8966-6d11-1eb9a73ae758Product name320231115
5518bf13-db2f-2e9c-3679-e70ecf03752cProduct name920210614
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710
ca834e59-e669-229c-9288-0ccb76dc373eProduct name920200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28Product name120190702
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-810-16ML - Milliliter50383-81007b58b7e-f033-4821-b850-0b40477b103612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR SUSPENSION [HI-TECH PHARMACAL CO., INC.]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR SUSPENSION [HI-TECH PHARMACAL CO., INC.]2
BANANAINACTIVE INGREDIENT4AJZ4765R9ACYCLOVIR SUSPENSION [HI-TECH PHARMACAL CO., INC.]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311ACYCLOVIR SUSPENSION [HI-TECH PHARMACAL CO., INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR SUSPENSION [HI-TECH PHARMACAL CO., INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACYCLOVIR SUSPENSION [HI-TECH PHARMACAL CO., INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TACYCLOVIR SUSPENSION [HI-TECH PHARMACAL CO., INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHACYCLOVIR SUSPENSION [HI-TECH PHARMACAL CO., INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RACYCLOVIR SUSPENSION [HI-TECH PHARMACAL CO., INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RACYCLOVIR SUSPENSION [HI-TECH PHARMACAL CO., INC.]2
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311ACYCLOVIR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACYCLOVIR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TACYCLOVIR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHACYCLOVIR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RACYCLOVIR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RACYCLOVIR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-810ACYCLOVIR SUSPENSION [AKORN]8Legacy NDC20220920_62bdcf22-51f3-4c81-9bd4-a2dc48bec580.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-810-1650383081016473 mL in 1 BOTTLE (50383-810-16) 473 ml2005-06-070000-00-00NoNoCurrent