FDA.reportPublic FDA data

Acyclovir

Product NDC
0472-0082
11-digit product format
004720082
Labeler code
0472
Product ID
0472-0082_6f58843b-1a91-42b4-b03c-7cad93c931d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
SUSPENSION
Route
ORAL
Labeler
Actavis Pharma, Inc.
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
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
0472-0082-16Acyclovir473 mL in 1 BOTTLESUSPENSION4737

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0082-16ML - Milliliter0472-0082eade4ea7-b374-4a92-be34-c18472a48b8912013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311ACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]2
SORBITOLINACTIVE INGREDIENT506T60A25RACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-0082ACYCLOVIR SUSPENSION [ACTAVIS PHARMA, INC.]6Current NDC, Legacy NDC, 1 package rows20250424_a4c1305c-f18c-4fb0-83d8-2822341f2dfa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307730acyclovir 200 MG in 5 mL Oral SuspensionPSNa4c1305c-f18c-4fb0-83d8-2822341f2dfa7
307730acyclovir 40 MG/ML Oral SuspensionSCDa4c1305c-f18c-4fb0-83d8-2822341f2dfa7
307730acyclovir 200 MG per 5 ML Oral SuspensionSYa4c1305c-f18c-4fb0-83d8-2822341f2dfa7
307730acycycloguanosine 40 MG/ML Oral SuspensionSYa4c1305c-f18c-4fb0-83d8-2822341f2dfa7
307730acyclovir 200 MG in 5 mL Oral SuspensionPSNda5a809c-6ddc-4609-9a34-ccb3d2d439765
307730acyclovir 40 MG/ML Oral SuspensionSCDda5a809c-6ddc-4609-9a34-ccb3d2d439765
307730acyclovir 200 MG per 5 ML Oral SuspensionSYda5a809c-6ddc-4609-9a34-ccb3d2d439765
307730acycycloguanosine 40 MG/ML Oral SuspensionSYda5a809c-6ddc-4609-9a34-ccb3d2d439765
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0082-1600472008216473 mL in 1 BOTTLE (0472-0082-16) 473 ml2002-09-030000-00-00NoNoCurrent