FDA.reportPublic FDA data

acyclovir

Product NDC
68788-8247
11-digit product format
687888247
Labeler code
68788
Product ID
68788-8247_39622b79-6854-4436-a668-25d11c8f3198
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc
Application
ANDA205974
Marketing category
ANDA
Marketing start
2022-08-19
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
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
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
68788-8247-1acyclovir1 in 1 CARTONOINTMENT15
68788-8247-1acyclovir15 g in 1 TUBEOINTMENT155

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8247-1GM - Gram68788-8247a47041dd-0f45-47e7-a6d0-306e802a01d312022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8247ACYCLOVIR OINTMENT [PREFERRED PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 2 package rows20241229_c11c1136-7421-48ff-86d2-39507e80a04c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197312acyclovir 5 % Topical OintmentPSNc11c1136-7421-48ff-86d2-39507e80a04c5
197312acyclovir 0.05 MG/MG Topical OintmentSCDc11c1136-7421-48ff-86d2-39507e80a04c5
197312acyclovir 5 % Topical OintmentSYc11c1136-7421-48ff-86d2-39507e80a04c5
197312acyclovir 50 MG per 1 GM Topical OintmentSYc11c1136-7421-48ff-86d2-39507e80a04c5
197312acycycloguanosine 0.05 MG/MG Topical OintmentSYc11c1136-7421-48ff-86d2-39507e80a04c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8247-1687888247011 TUBE in 1 CARTON (68788-8247-1) / 15 g in 1 TUBE1 tube2022-08-190000-00-00NoNoCurrent