FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
59651-493
11-digit product format
596510493
Labeler code
59651
Product ID
59651-493_9520c707-eb6f-4343-9e28-9820a0d22ddd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216331
Marketing category
ANDA
Marketing start
2022-03-31
Substance
ACYCLOVIR
Active strength
200 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui307730

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
59651-493-47ACYCLOVIR473 mL in 1 BOTTLESUSPENSION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-493-47ML - Milliliter59651-4938bf7d243-c3ef-442f-b27e-cff807c6326612024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-493ACYCLOVIR SUSPENSION [AUROBINDO PHARMA LIMITED]1Current NDC, Legacy NDC, 1 package rows20220407_37761c4f-4378-472e-a41b-6a1d40575cb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307730acyclovir 200 MG in 5 mL Oral SuspensionPSN37761c4f-4378-472e-a41b-6a1d40575cb72
307730acyclovir 40 MG/ML Oral SuspensionSCD37761c4f-4378-472e-a41b-6a1d40575cb72
307730acyclovir 200 MG per 5 ML Oral SuspensionSY37761c4f-4378-472e-a41b-6a1d40575cb72
307730acycycloguanosine 40 MG/ML Oral SuspensionSY37761c4f-4378-472e-a41b-6a1d40575cb72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-493-4759651049347473 mL in 1 BOTTLE (59651-493-47) 473 ml2022-03-310000-00-00NoNoCurrent