FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
60687-856
11-digit product format
606870856
Labeler code
60687
Product ID
60687-856_4a03039d-ae31-10ea-e063-6294a90a1e30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA074891
Marketing category
ANDA
Marketing start
2025-03-24
Substance
ACYCLOVIR
Active strength
400 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
ACYCLOVIR400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197311, 197313

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
60687-856-01ACYCLOVIR100 in 1 CARTONTABLET1005
60687-856-11ACYCLOVIR1 in 1 BLISTER PACKTABLET15
60687-856-65ACYCLOVIR50 in 1 CARTONTABLET505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-856-01EA - Each60687-85604e7d050-7006-4f1b-8fc2-1a7f140637cd12025-03-04
60687-856-11EA - Each60687-856d0c3eaba-6635-4621-9263-edc4013af97912025-03-04
60687-856-65EA - Each60687-856e13bfe0f-2f7f-4969-8666-9c89d55ffb8512026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-856ACYCLOVIR TABLET [AMERICAN HEALTH PACKAGING]2Current NDC, 3 package rows20250507_05f42300-2a06-45f1-a9b9-6e5c84ae58ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN05f42300-2a06-45f1-a9b9-6e5c84ae58ec5
197313acyclovir 800 MG Oral TabletPSN05f42300-2a06-45f1-a9b9-6e5c84ae58ec5
197311acyclovir 400 MG Oral TabletSCD05f42300-2a06-45f1-a9b9-6e5c84ae58ec5
197313acyclovir 800 MG Oral TabletSCD05f42300-2a06-45f1-a9b9-6e5c84ae58ec5
197311acycycloguanosine 400 MG Oral TabletSY05f42300-2a06-45f1-a9b9-6e5c84ae58ec5
197313acycycloguanosine 800 MG Oral TabletSY05f42300-2a06-45f1-a9b9-6e5c84ae58ec5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-856-0160687085601100 BLISTER PACK in 1 CARTON (60687-856-01) / 1 TABLET in 1 BLISTER PACK (60687-856-11) 100 blister pack2025-03-24NoNoHistorical
60687-856-11606870856111 in 1 BLISTER PACKHistorical
60687-856-656068708566550 BLISTER PACK in 1 CARTON (60687-856-65) / 1 TABLET in 1 BLISTER PACK (60687-856-11) 50 blister pack2026-02-04NoNoHistorical