FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
0904-7519
11-digit product format
009047519
Labeler code
0904
Product ID
0904-7519_4c7500fc-8cbb-4b19-bcea-81f562eafe22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA074889
Marketing category
ANDA
Marketing start
2025-10-24
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
0904-7519-61ACYCLOVIR1 in 1 BLISTER PACKCAPSULE12
0904-7519-61ACYCLOVIR100 in 1 CARTONCAPSULE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7519-61EA - Each0904-75191babe99d-9c7b-401e-9db0-d016162b8af212025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN9b254eed-8ea1-469b-bf27-f5670cd99e8d2
197310acyclovir 200 MG Oral CapsuleSCD9b254eed-8ea1-469b-bf27-f5670cd99e8d2
197310acycycloguanosine 200 MG Oral CapsuleSY9b254eed-8ea1-469b-bf27-f5670cd99e8d2
197310acyclovir 200 MG Oral CapsulePSN4cc7d67f-35fa-4238-a581-4810645083cf1
197310acyclovir 200 MG Oral CapsuleSCD4cc7d67f-35fa-4238-a581-4810645083cf1
197310acycycloguanosine 200 MG Oral CapsuleSY4cc7d67f-35fa-4238-a581-4810645083cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7519-6100904751961100 BLISTER PACK in 1 CARTON (0904-7519-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2025-10-24NoNoHistorical