FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
71205-243
11-digit product format
712050243
Labeler code
71205
Product ID
71205-243_c225060d-b6e8-4343-8e4d-b52067f05792
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075677
Marketing category
ANDA
Marketing start
2006-03-20
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACYCLOVIR
Listing expiration
2026-12-31

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
71205-243-30ACYCLOVIR30 in 1 BOTTLECAPSULE303
71205-243-60ACYCLOVIR60 in 1 BOTTLECAPSULE603
71205-243-90ACYCLOVIR90 in 1 BOTTLECAPSULE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-243ACYCLOVIR CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20201229_8d7994a6-5bd2-494d-89c1-b03755d4f2c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN8d7994a6-5bd2-494d-89c1-b03755d4f2c33
197310acyclovir 200 MG Oral CapsuleSCD8d7994a6-5bd2-494d-89c1-b03755d4f2c33
197310acycycloguanosine 200 MG Oral CapsuleSY8d7994a6-5bd2-494d-89c1-b03755d4f2c33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-243-307120502433030 CAPSULE in 1 BOTTLE (71205-243-30) 30 capsule2019-03-010000-00-00NoNoCurrent
71205-243-607120502436060 CAPSULE in 1 BOTTLE (71205-243-60) 60 capsule2019-03-010000-00-00NoNoCurrent
71205-243-907120502439090 CAPSULE in 1 BOTTLE (71205-243-90) 90 capsule2019-03-010000-00-00NoNoCurrent