FDA.reportPublic FDA data

acyclovir

Product NDC
70436-030
11-digit product format
704360030
Labeler code
70436
Product ID
70436-030_1280dbca-a2d7-49cf-e063-6394a90a7596
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA218111
Marketing category
ANDA
Marketing start
2024-03-01
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

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
70436-030-82acyclovir10 in 1 CARTONINJECTION, SOLUTION102
70436-030-82acyclovir10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-030-82ML - Milliliter70436-030d231fbda-5cf0-4e25-be72-0f2abdb7b81e12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-030ACYCLOVIR INJECTION, SOLUTION [SLATE RUN PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240302_889bccd1-3793-40ce-bca2-c8c9cf6b7488.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734932acyclovir sodium 500 MG in 10 ML InjectionPSN889bccd1-3793-40ce-bca2-c8c9cf6b74882
173493210 ML acyclovir 50 MG/ML InjectionSCD889bccd1-3793-40ce-bca2-c8c9cf6b74882
173493210 ML acycycloguanosine 50 MG/ML InjectionSY889bccd1-3793-40ce-bca2-c8c9cf6b74882
1734932acyclovir 50 MG/ML (equivalent to acyclovir sodium 54.9 MG/ML) per 10 ML InjectionSY889bccd1-3793-40ce-bca2-c8c9cf6b74882
1734932acyclovir 500 MG per 10 ML InjectionSY889bccd1-3793-40ce-bca2-c8c9cf6b74882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70436-030-827043600308210 VIAL, SINGLE-DOSE in 1 CARTON (70436-030-82) / 10 mL in 1 VIAL, SINGLE-DOSE2024-03-01NoNoHistorical