Acyclovir Sodium Injection, Solution
NDC 55150-154

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 55150-154?
  4. Acyclovir Sodium Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Acyclovir Sodium is a ANDA-approved product labeled by Eugia Us Llc. This medication is used in certain people to treat outbreaks of herpes simplex infection of the skin (such as on the genitals), mucous membrane areas (such as the mouth, nose), or brain. It is supplied as a injection, solution for intravenous administration. This product entry covers the primary NDC 55150-154 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
55150-154
Proprietary Name:
Acyclovir Sodium
Non-Proprietary Name: [1]
Acyclovir Sodium
Substance Name: [2]
Acyclovir Sodium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

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.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.

Labeler & Regulatory Data

Labeler Name: [5]
Eugia Us Llc
Labeler Code:
55150
Product Label ID:
ae921e4e-b8ae-4a45-acc1-32e5e719812b
FDA Application Number: [6]
ANDA203701
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
10-11-2013
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 55150-154?

The NDC code 55150-154 is assigned by the FDA to the product Acyclovir Sodium. This pharmaceutical product is labeled by Eugia Us Llc and is currently categorized as listed product. The medication is a injection, solution administered via intravenous route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 55150-154-10, 55150-154-11. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This medication is used in certain people to treat outbreaks of herpes simplex infection of the skin (such as on the genitals), mucous membrane areas (such as the mouth, nose), or brain. It is also used in certain people to treat shingles infection. The viruses that cause these infections live in the body quietly until an outbreak occurs. Acyclovir does not cure these infections, but can speed healing of the sores, decrease pain/itching/formation of new sores, and lower the risk of other problems from the virus (e.g., infection spreading to other parts of the body/organs, persistent pain after sores heal).

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ACYCLOVIR SODIUM 500 mg/10mL - A GUANOSINE analog that acts as an antimetabolite. Viruses are especially susceptible. Used especially against herpes.
  • ACYCLOVIR SODIUM 500 mg/10mL - A GUANOSINE analog that acts as an antimetabolite. Viruses are especially susceptible. Used especially against herpes.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Acyclovir Injection


Acyclovir injection is used to treat first-time or repeat outbreaks of herpes simplex (a herpes virus infection of the skin and mucus membranes) and to treat herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past) in people with weak immune systems. It is also used to treat first-time genital herpes outbreaks (a herpes virus infection that causes sores to form around the genitals and rectum from time to time) in people with normal immune systems. Acyclovir injection is used to treat herpes simplex encephalitis (brain infection with swelling caused by the herpes virus) and herpes infections in newborn infants. Acyclovir injection is in a class of antiviral medications called synthetic nucleoside analogues. It works by stopping the spread of the herpes virus in the body. Acyclovir injection will not cure genital herpes and may not stop the spread of genital herpes to other people.
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Product & Regulatory Definitions
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.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".