FDA.reportPublic FDA data

Acyclovir

Product NDC
31722-681
11-digit product format
317220681
Labeler code
31722
Product ID
31722-681_e87a8107-f6d9-5bf2-e053-2a95a90afc80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
SUSPENSION
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA215669
Marketing category
ANDA
Marketing start
2022-07-01
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
31722-681-47Acyclovir473 mL in 1 BOTTLESUSPENSION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-681-47ML - Milliliter31722-6816cfac516-beb2-40ee-94e5-480240e5b2d612022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-681ACYCLOVIR (ACYCLOVIR) SUSPENSION [CAMBER PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 1 package rows20220913_2ca1395f-96b4-4543-8eed-bd07c62bbc7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307730acyclovir 200 MG in 5 mL Oral SuspensionPSN2ca1395f-96b4-4543-8eed-bd07c62bbc7c2
307730acyclovir 40 MG/ML Oral SuspensionSCD2ca1395f-96b4-4543-8eed-bd07c62bbc7c2
307730acyclovir 200 MG per 5 ML Oral SuspensionSY2ca1395f-96b4-4543-8eed-bd07c62bbc7c2
307730acycycloguanosine 40 MG/ML Oral SuspensionSY2ca1395f-96b4-4543-8eed-bd07c62bbc7c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-681-4731722068147473 mL in 1 BOTTLE (31722-681-47) 473 ml2022-07-010000-00-00NoNoCurrent