FDA.reportPublic FDA data

acyclovir

Product NDC
70954-188
11-digit product format
709540188
Labeler code
70954
Product ID
70954-188_87d55aa5-78a8-458e-9a82-f4f36d9d1c9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
SUSPENSION
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA212252
Marketing category
ANDA
Marketing start
2020-07-13
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
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/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
70954-188-10acyclovir473 mL in 1 BOTTLESUSPENSION4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-188-10ML - Milliliter70954-1882f4e98ec-371f-4bbd-a467-72e833a955bb12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-188ACYCLOVIR SUSPENSION [NOVITIUM PHARMA LLC]3Current NDC, Legacy NDC, 1 package rows20210818_8208711c-18ba-4615-b932-3c0bb7e6efae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307730acyclovir 200 MG in 5 mL Oral SuspensionPSN8208711c-18ba-4615-b932-3c0bb7e6efae4
307730acyclovir 40 MG/ML Oral SuspensionSCD8208711c-18ba-4615-b932-3c0bb7e6efae4
307730acyclovir 200 MG per 5 ML Oral SuspensionSY8208711c-18ba-4615-b932-3c0bb7e6efae4
307730acycycloguanosine 40 MG/ML Oral SuspensionSY8208711c-18ba-4615-b932-3c0bb7e6efae4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-188-1070954018810473 mL in 1 BOTTLE (70954-188-10) 473 ml2020-07-130000-00-00NoNoCurrent