FDA.reportPublic FDA data

Acyclovir

Product NDC
65162-835
11-digit product format
651620835
Labeler code
65162
Product ID
65162-835_5701d6c5-b948-4d7b-ab6e-99b5c559dbf5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA204605
Marketing category
ANDA
Marketing start
2014-01-03
Substance
ACYCLOVIR
Active strength
50 mg/g
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
ACYCLOVIR50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197312

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
65162-835-94Acyclovir1 in 1 CARTONOINTMENT113
65162-835-94Acyclovir15 g in 1 TUBEOINTMENT1513
65162-835-96Acyclovir1 in 1 CARTONOINTMENT113
65162-835-96Acyclovir30 g in 1 TUBEOINTMENT3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-835-94GM - Gram65162-835f9b75730-2256-4790-8c10-1e8345c340bb12015-07-20
65162-835-96GM - Gram65162-835acecaa7a-ad5e-4a04-99e0-2bab2e42901d12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR OINTMENT [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR OINTMENT [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACYCLOVIR OINTMENT [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-835ACYCLOVIR OINTMENT [AMNEAL PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 4 package rows20241025_269e2203-347d-40dc-b794-11cf34690f27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197312acyclovir 5 % Topical OintmentPSN269e2203-347d-40dc-b794-11cf34690f2713
197312acyclovir 0.05 MG/MG Topical OintmentSCD269e2203-347d-40dc-b794-11cf34690f2713
197312acyclovir 5 % Topical OintmentSY269e2203-347d-40dc-b794-11cf34690f2713
197312acyclovir 50 MG per 1 GM Topical OintmentSY269e2203-347d-40dc-b794-11cf34690f2713
197312acycycloguanosine 0.05 MG/MG Topical OintmentSY269e2203-347d-40dc-b794-11cf34690f2713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-835-94651620835941 TUBE in 1 CARTON (65162-835-94) / 15 g in 1 TUBE1 tube2014-01-030000-00-00NoNoCurrent
65162-835-96651620835961 TUBE in 1 CARTON (65162-835-96) / 30 g in 1 TUBE1 tube2014-01-030000-00-00NoNoCurrent