FDA.reportPublic FDA data

acyclovir

Product NDC
68382-049
11-digit product format
683820049
Labeler code
68382
Product ID
68382-049_515388e8-636f-42f6-a39e-bb4fc7c2e7cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA206535
Marketing category
ANDA
Marketing start
2018-11-27
Substance
ACYCLOVIR SODIUM
Active strength
50 mg/mL
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
ACYCLOVIR SODIUM50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927L42J563
Rxcui1734932, 1734934

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
68382-049-01acyclovir20 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION207
68382-049-10acyclovir10 in 1 CARTONINJECTION, SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-049-10ML - Milliliter68382-0497d2de73e-1e84-4494-81a3-fed9a29765e512021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-049ACYCLOVIR INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS (USA) INC.]7Current NDC, Legacy NDC, 2 package rows20211202_69a98000-adef-4323-89a7-09e035a257d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734934acyclovir sodium 1000 MG in 20 ML InjectionPSN69a98000-adef-4323-89a7-09e035a257d47
1734932acyclovir sodium 500 MG in 10 ML InjectionPSN69a98000-adef-4323-89a7-09e035a257d47
173493210 ML acyclovir 50 MG/ML InjectionSCD69a98000-adef-4323-89a7-09e035a257d47
173493420 ML acyclovir 50 MG/ML InjectionSCD69a98000-adef-4323-89a7-09e035a257d47
173493210 ML acycycloguanosine 50 MG/ML InjectionSY69a98000-adef-4323-89a7-09e035a257d47
173493420 ML acycycloguanosine 50 MG/ML InjectionSY69a98000-adef-4323-89a7-09e035a257d47
1734934acyclovir 1000 MG per 20 ML InjectionSY69a98000-adef-4323-89a7-09e035a257d47
1734932acyclovir 50 MG/ML (equivalent to acyclovir sodium 54.9 MG/ML) per 10 ML InjectionSY69a98000-adef-4323-89a7-09e035a257d47
1734934acyclovir 50 MG/ML (equivalent to acyclovir sodium 54.9 MG/ML) per 20 ML InjectionSY69a98000-adef-4323-89a7-09e035a257d47
1734932acyclovir 500 MG per 10 ML InjectionSY69a98000-adef-4323-89a7-09e035a257d47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-049-016838200490120 mL in 1 VIAL, SINGLE-USE20 mlHistorical
68382-049-106838200491010 VIAL, SINGLE-USE in 1 CARTON (68382-049-10) / 20 mL in 1 VIAL, SINGLE-USE (68382-049-01) 2018-11-270000-00-00NoNoCurrent