FDA.reportPublic FDA data

acyclovir

Product NDC
16714-885
11-digit product format
167140885
Labeler code
16714
Product ID
16714-885_b8c9f3ec-f227-421a-be72-29e8d533ab1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Northstar Rx LLC
Application
ANDA205510
Marketing category
ANDA
Marketing start
2017-07-31
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
16714-885-01acyclovir15 g in 1 TUBEOINTMENT153
16714-885-01acyclovir1 in 1 CARTONOINTMENT13
16714-885-02acyclovir1 in 1 CARTONOINTMENT13
16714-885-02acyclovir30 g in 1 TUBEOINTMENT303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-885-01GM - Gram16714-88535b4adfd-b4b6-4734-8a4e-9967e0b768a712019-04-11
16714-885-02GM - Gram16714-885d4a44468-693d-4d56-bb78-e090116fd87212019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-885ACYCLOVIR OINTMENT [NORTHSTAR RX LLC]2Current NDC, Legacy NDC, 4 package rows20231021_6788f3c6-b79c-4f3f-9a73-10c8d3a38267.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197312acyclovir 5 % Topical OintmentPSN41d5ae3e-51c0-263b-e063-6394a90a33123
197312acyclovir 5 % Topical OintmentPSN6788f3c6-b79c-4f3f-9a73-10c8d3a382673
197312acyclovir 0.05 MG/MG Topical OintmentSCD41d5ae3e-51c0-263b-e063-6394a90a33123
197312acyclovir 0.05 MG/MG Topical OintmentSCD6788f3c6-b79c-4f3f-9a73-10c8d3a382673
197312acyclovir 5 % Topical OintmentSY41d5ae3e-51c0-263b-e063-6394a90a33123
197312acyclovir 5 % Topical OintmentSY6788f3c6-b79c-4f3f-9a73-10c8d3a382673
197312acyclovir 50 MG per 1 GM Topical OintmentSY41d5ae3e-51c0-263b-e063-6394a90a33123
197312acyclovir 50 MG per 1 GM Topical OintmentSY6788f3c6-b79c-4f3f-9a73-10c8d3a382673
197312acycycloguanosine 0.05 MG/MG Topical OintmentSY41d5ae3e-51c0-263b-e063-6394a90a33123
197312acycycloguanosine 0.05 MG/MG Topical OintmentSY6788f3c6-b79c-4f3f-9a73-10c8d3a382673
197312acyclovir 5 % Topical OintmentPSN942632d8-08cd-4003-aec0-1c6d5c09bc151
197312acyclovir 0.05 MG/MG Topical OintmentSCD942632d8-08cd-4003-aec0-1c6d5c09bc151
197312acyclovir 5 % Topical OintmentSY942632d8-08cd-4003-aec0-1c6d5c09bc151
197312acyclovir 50 MG per 1 GM Topical OintmentSY942632d8-08cd-4003-aec0-1c6d5c09bc151
197312acycycloguanosine 0.05 MG/MG Topical OintmentSY942632d8-08cd-4003-aec0-1c6d5c09bc151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-885-01167140885011 TUBE in 1 CARTON (16714-885-01) / 15 g in 1 TUBE1 tube2018-12-310000-00-00NoNoCurrent
16714-885-02167140885021 TUBE in 1 CARTON (16714-885-02) / 30 g in 1 TUBE1 tube2018-12-310000-00-00NoNoCurrent