Acyclovir

Product NDC
81288-039
11-digit product format
812880039
Labeler code
81288
Product ID
81288-039_ed2d0aea-0a4c-41a4-b415-af5531106337
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
EMC PHARMA, LLC
Application
ANDA212173
Marketing category
ANDA
Marketing start
2022-07-29
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
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81288-039-01EA - Each81288-03915f500a5-e770-4964-bb2c-fdbcaf07cc8912022-10-06
81288-039-02EA - Each81288-039e54cf742-9200-4746-850c-157254ba519512022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81288-039ACYCLOVIR CAPSULE [EMC PHARMA, LLC]2Legacy NDC20250101_ff18ddde-a07d-47b6-86bc-92d0e80ccde1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81288-039-0181288003901100 CAPSULE in 1 BOTTLE (81288-039-01) 100 capsule2022-07-290000-00-00NoNoCurrent
81288-039-0281288003902500 CAPSULE in 1 BOTTLE (81288-039-02) 500 capsule2022-07-290000-00-00NoNoCurrent