FDA.reportPublic FDA data

Acyclovir

Product NDC
17856-8083
11-digit product format
178568083
Labeler code
17856
Product ID
17856-8083_4032ed04-0061-c22c-e063-6394a90a2ba1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA074738
Marketing category
ANDA
Marketing start
2002-09-03
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
17856-8083-1Acyclovir50 in 1 BOX, UNIT-DOSESUSPENSION501
17856-8083-1Acyclovir5 mL in 1 CUP, UNIT-DOSESUSPENSION51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307730acyclovir 200 MG in 5 mL Oral SuspensionPSN4032ce02-e2b3-d426-e063-6294a90ab6c91
307730acyclovir 40 MG/ML Oral SuspensionSCD4032ce02-e2b3-d426-e063-6294a90ab6c91
307730acyclovir 200 MG per 5 ML Oral SuspensionSY4032ce02-e2b3-d426-e063-6294a90ab6c91
307730acycycloguanosine 40 MG/ML Oral SuspensionSY4032ce02-e2b3-d426-e063-6294a90ab6c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
17856-8083-11785680830150 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-8083-1) / 5 mL in 1 CUP, UNIT-DOSE2025-10-01NoNoHistorical