Acyclovir

Product NDC
0904-7507
11-digit product format
009047507
Labeler code
0904
Product ID
0904-7507_a5909f5b-fb25-4050-990a-19d29eef0457
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA203834
Marketing category
ANDA
Marketing start
2025-01-28
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

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
0904-7507-61Acyclovir1 in 1 BLISTER PACKTABLET12
0904-7507-61Acyclovir100 in 1 CARTONTABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7507-61EA - Each0904-750752253ed3-2de0-405e-947f-83d88fe74d8f12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7507ACYCLOVIR TABLET [MAJOR PHARMACEUTICALS]1Current NDC, 2 package rows20250130_46150f19-ce5d-42a0-80a7-f96fda2b9879.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN46150f19-ce5d-42a0-80a7-f96fda2b98792
197311acyclovir 400 MG Oral TabletSCD46150f19-ce5d-42a0-80a7-f96fda2b98792
197311acycycloguanosine 400 MG Oral TabletSY46150f19-ce5d-42a0-80a7-f96fda2b98792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7507-6100904750761100 BLISTER PACK in 1 CARTON (0904-7507-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2025-01-28NoNoHistorical