FDA.reportPublic FDA data

Acyclovir

Product NDC
63629-2327
11-digit product format
636292327
Labeler code
63629
Product ID
63629-2327_ecd1aaae-ac08-4e8b-b43c-fbee2c7da05d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA201501
Marketing category
ANDA
Marketing start
2020-01-30
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
63629-2327-1Acyclovir30 g in 1 TUBEOINTMENT30102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2327-1GM - Gram63629-232767d5e5d8-6c89-412b-96d6-0124f12ff12312021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2327ACYCLOVIR OINTMENT [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240112_d04c696f-c072-46f7-9a92-9cbb476c827b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197312acyclovir 5 % Topical OintmentPSNd04c696f-c072-46f7-9a92-9cbb476c827b102
197312acyclovir 0.05 MG/MG Topical OintmentSCDd04c696f-c072-46f7-9a92-9cbb476c827b102
197312acyclovir 5 % Topical OintmentSYd04c696f-c072-46f7-9a92-9cbb476c827b102
197312acyclovir 50 MG per 1 GM Topical OintmentSYd04c696f-c072-46f7-9a92-9cbb476c827b102
197312acycycloguanosine 0.05 MG/MG Topical OintmentSYd04c696f-c072-46f7-9a92-9cbb476c827b102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2327-16362923270130 g in 1 TUBE (63629-2327-1) 30 g2021-04-190000-00-00NoNoCurrent