FDA.reportPublic FDA data

Acyclovir suspension

Product NDC
17856-2170
11-digit product format
178562170
Labeler code
17856
Product ID
17856-2170_5105272f-cff9-8898-e063-6394a90aabb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
SUSPENSION
Route
ORAL
Labeler
Atlantic Biologicals Corp.
Application
ANDA217393
Marketing category
ANDA
Marketing start
2023-03-09
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 suspension
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
17856-2170-1Acyclovir suspension72 in 1 CASESUSPENSION721
17856-2170-1Acyclovir suspension5 mL in 1 CUP, UNIT-DOSESUSPENSION51
17856-2170-2Acyclovir suspension10 mL in 1 CUP, UNIT-DOSESUSPENSION101
17856-2170-2Acyclovir suspension72 in 1 CASESUSPENSION721

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307730acyclovir 200 MG in 5 mL Oral SuspensionPSN5105272f-cff8-8898-e063-6394a90aabb51
307730acyclovir 40 MG/ML Oral SuspensionSCD5105272f-cff8-8898-e063-6394a90aabb51
307730acyclovir 200 MG per 5 ML Oral SuspensionSY5105272f-cff8-8898-e063-6394a90aabb51
307730acycycloguanosine 40 MG/ML Oral SuspensionSY5105272f-cff8-8898-e063-6394a90aabb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
17856-2170-11785621700172 CUP, UNIT-DOSE in 1 CASE (17856-2170-1) / 5 mL in 1 CUP, UNIT-DOSE2026-05-04NoNoHistorical
17856-2170-21785621700272 CUP, UNIT-DOSE in 1 CASE (17856-2170-2) / 10 mL in 1 CUP, UNIT-DOSE2026-05-04NoNoHistorical