NDC Package Code 63323-325-10
The NDC Code 63323-325-10 is assigned to a package of 10 vial, single-dose in 1 tray > 10 ml in 1 vial, single-dose (63323-325-03) of Acyclovir, a human prescription drug labeled by Fresenius Kabi Usa, Llc. The product's dosage form is injection, solution and is administered via intravenous form.
|Field Name||Field Value|
|Package Description||10 VIAL, SINGLE-DOSE in 1 TRAY > 10 mL in 1 VIAL, SINGLE-DOSE (63323-325-03)|
|Proprietary Name||Acyclovir 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.
|Non-Proprietary Name||Acyclovir Sodium 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.
|Drug Uses||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||63323032510 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.
|Billing Unit||ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.|
|Product Type||Human Prescription Drug 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.
|Labeler Name||Fresenius Kabi Usa, Llc|
|Dosage Form||Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.|
|Sample Package||No Sample Package?
This field Indicates whether this package is a sample packaging or not.
|Marketing Category||ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.
|FDA Application Number||ANDA074930 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.
|Start Marketing Date||10-17-2000 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
|Listing Expiration Date||12-31-2021 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.
|Exclude Flag||N 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".
NDC HCPCS Crosswalk
This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.
NDC 63323-325-10 HCPCS crosswalk information with package details and bill units information.
|NDC Billing Code||HCPCS Code||HCPCS Code Desc.||Dosage||Package Size||Package Quantity||Billable Units||Billable Units / Pkg|
|63323032510||J0133||Acyclovir injection||5 MG||20||10||100||1000|
* Please review the disclaimer below.
Other Product Packages
The following packages are also available for Acyclovir with product NDC 63323-325.
|NDC Package Code||Package Description|
|63323-325-14||10 VIAL, SINGLE-DOSE in 1 TRAY > 10 mL in 1 VIAL, SINGLE-DOSE (63323-325-41)|
|63323-325-20||10 VIAL, SINGLE-DOSE in 1 TRAY > 20 mL in 1 VIAL, SINGLE-DOSE (63323-325-09)|
|63323-325-24||10 VIAL, SINGLE-DOSE in 1 TRAY > 20 mL in 1 VIAL, SINGLE-DOSE (63323-325-43)|
* Please review the disclaimer below.