FDA.reportPublic FDA data

Acyclovir

Product NDC
71205-578
11-digit product format
712050578
Labeler code
71205
Product ID
71205-578_e95e1c62-32d4-46b8-ab0f-c662b837f9b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA206261
Marketing category
ANDA
Marketing start
2017-08-17
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
71205-578-30Acyclovir30 in 1 BOTTLE, PLASTICCAPSULE302
71205-578-60Acyclovir60 in 1 BOTTLE, PLASTICCAPSULE602
71205-578-90Acyclovir90 in 1 BOTTLE, PLASTICCAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-578-30EA - Each71205-578b8ea24f1-a5fd-471c-ace2-9b59e71fa24a12021-07-15
71205-578-90EA - Each71205-57824b34128-7b80-404b-9124-78c0d0c73c1012021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-578ACYCLOVIR CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220816_e8056ec6-d2dc-48af-8550-82726af1c5c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNe8056ec6-d2dc-48af-8550-82726af1c5c52
197310acyclovir 200 MG Oral CapsuleSCDe8056ec6-d2dc-48af-8550-82726af1c5c52
197310acycycloguanosine 200 MG Oral CapsuleSYe8056ec6-d2dc-48af-8550-82726af1c5c52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-578-307120505783030 CAPSULE in 1 BOTTLE, PLASTIC (71205-578-30) 30 capsule2021-06-100000-00-00NoNoCurrent
71205-578-607120505786060 CAPSULE in 1 BOTTLE, PLASTIC (71205-578-60) 60 capsule2021-06-100000-00-00NoNoCurrent
71205-578-907120505789090 CAPSULE in 1 BOTTLE, PLASTIC (71205-578-90) 90 capsule2021-06-100000-00-00NoNoCurrent