NDC 65162-835-94 Acyclovir
Ointment Topical

Package Information

The NDC Code 65162-835-94 is assigned to a package of 1 tube in 1 carton > 15 g in 1 tube of Acyclovir, a human prescription drug labeled by Amneal Pharmaceuticals Llc. The product's dosage form is ointment and is administered via topical form.

Field Name Field Value
NDC Code 65162-835-94
Package Description 1 TUBE in 1 CARTON > 15 g in 1 TUBE
Product Code 65162-835
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Acyclovir
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Acyclovir
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
Acyclovir is used to treat infections caused by certain types of viruses. It treats cold sores around the mouth (caused by herpes simplex), shingles (caused by herpes zoster), and chickenpox. This medication is also used to treat outbreaks of genital herpes. In people with frequent outbreaks, acyclovir is used to help reduce the number of future episodes. Acyclovir is an antiviral drug. However, it is not a cure for these infections. The viruses that cause these infections continue to live in the body even between outbreaks. Acyclovir decreases the severity and length of these outbreaks. It helps the sores heal faster, keeps new sores from forming, and decreases pain/itching. This medication may also help reduce how long pain remains after the sores heal. In addition, in people with a weakened immune system, acyclovir can decrease the risk of the virus spreading to other parts of the body and causing serious infections.
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
65162083594
Billing Unit GM - Billing unit of "gram" is used when a product is measured by its weight.
Estimated Billable Units per Package 15 GM
NADAC Wholesale Price per Unit National Average Drug Acquisition Cost (NADAC)
The National Average Drug Acquisition Cost (NADAC) wholesale price per unit for NDC 65162-835-94 is $0.77302 and is up-to-date as of 11-30-2022. This product is billed per "GM" gram and contains an estimated amount of 15 billable units per package. The estimated wholesale price for the this package based on the lastest NADAC pricing survey is $
$0.77302
NDC to RxNorm Crosswalk
  • RxCUI: 197312 - acyclovir 5 % Topical Ointment
  • RxCUI: 197312 - acyclovir 0.05 MG/MG Topical Ointment
  • RxCUI: 197312 - acyclovir 50 MG per 1 GM Topical Ointment
  • RxCUI: 197312 - acycycloguanosine 0.05 MG/MG Topical Ointment
  • Product Type What kind of product is this?
    Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
    Human Prescription Drug
    Labeler Name Amneal Pharmaceuticals Llc
    Dosage Form Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
    Administration Route(s)
    • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    Active Ingredient(s)
    Pharmacologic Class(es)
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    No
    Marketing Category What is the Marketing Category?
    Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    FDA Application Number What is the FDA Application Number?
    This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
    ANDA204605
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.
    01-03-2014
    Listing Expiration Date What is the Listing Expiration Date?
    This is the date when the listing record will expire if not updated or certified by the product labeler.
    12-31-2023
    Exclude Flag What is the NDC Exclude Flag?
    This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
    N
    NDC Code Structure

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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    Other Product Packages

    The following packages are also available for Acyclovir with product NDC 65162-835.

    NDC Package CodePackage Description
    65162-835-961 TUBE in 1 CARTON > 30 g in 1 TUBE

    * Please review the disclaimer below.