FDA.reportPublic FDA data

acyclovir

Product NDC
70518-3436
11-digit product format
705183436
Labeler code
70518
Product ID
70518-3436_5071b891-7d0a-23d6-e063-6294a90a4b33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204313
Marketing category
ANDA
Marketing start
2022-06-14
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
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
IngredientStrength
ACYCLOVIR200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197310

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3436-0acyclovir30 in 1 BLISTER PACKCAPSULE307
70518-3436-1acyclovir50 in 1 BOXCAPSULE507
70518-3436-2acyclovir1 in 1 POUCHCAPSULE17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3436ACYCLOVIR CAPSULE [REMEDYREPACK INC.]3Current NDC, Legacy NDC, 3 package rows20240112_0990b625-5dfe-4810-b5b4-ac5948599e79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN0990b625-5dfe-4810-b5b4-ac5948599e797
197310acyclovir 200 MG Oral CapsuleSCD0990b625-5dfe-4810-b5b4-ac5948599e797
197310acycycloguanosine 200 MG Oral CapsuleSY0990b625-5dfe-4810-b5b4-ac5948599e797

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3436-07051834360030 CAPSULE in 1 BLISTER PACK (70518-3436-0) 30 capsule2022-06-140000-00-00NoNoCurrent
70518-3436-17051834360150 POUCH in 1 BOX (70518-3436-1) / 1 CAPSULE in 1 POUCH (70518-3436-2) 50 pouch2026-04-24NoNoHistorical
70518-3436-2705183436021 in 1 POUCHHistorical