1. Home
  2. Labeler Index
  3. Saol Therapeutics Inc.
  4. 70257-052
  5. NDC Package Code: 70257-052-51 Hepagam B

NDC Package 70257-052-51 Hepagam B

Hepatitis B Immune Globulin Intravenous (human) Injection Intramuscular; Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
70257-052-51
Package Description:
1 VIAL, GLASS in 1 CARTON / 1 mL in 1 VIAL, GLASS (70257-052-11)
Product Code:
70257-052
Proprietary Name:
Hepagam B
Non-Proprietary Name:
Hepatitis B Immune Globulin Intravenous (human)
Substance Name:
Human Hepatitis B Virus Immune Globulin
Usage Information:
This medication is used to prevent a certain serious virus infection (hepatitis B) in people who have been exposed to this virus under certain conditions (such as direct contact with blood or body fluids containing this virus). Certain brands of this medication may also be given after a liver transplant to prevent return of hepatitis B infection in people with previous infection. Ask your doctor or pharmacist if you have questions about your particular brand. This medication is made from healthy human blood that has high levels of certain defensive substances (antibodies) that help fight hepatitis B.
11-Digit NDC Billing Format:
70257005251
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1658125 - hepatitis B immune globulin (human) > 312 UNT/ML in 5 ML Injection
  • RxCUI: 1658125 - 5 ML hepatitis B immune globulin 312 UNT/ML Injection
  • RxCUI: 1658147 - hepatitis B immune globulin (human) > 312 UNT/ML in 1 ML Injection
  • RxCUI: 1658147 - 1 ML hepatitis B immune globulin 312 UNT/ML Injection
  • RxCUI: 1658159 - HepaGam B > 312 UNT/ML in 1 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Saol Therapeutics Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 312 [iU]/mL
    • Pharmacologic Class(es):
  • Human Immunoglobulin - [EPC] (Established Pharmacologic Class)
  • Immunoglobulins - [CS]
  • Passively Acquired Immunity - [PE] (Physiologic Effect)
  • Virus Neutralization - [MoA] (Mechanism of Action)
  • Virus-specific Hyperimmune Globulins - [EXT]
    • Sample Package:
    No
    FDA Application Number:
    BLA125035
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    03-01-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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.

    * Please review the disclaimer below.

    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 70257-052-51 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    70257005251J1573Hepagam b intravenous, inj0.5 ML1122
    70257005251J1571Hepagam b im injection0.5 ML1122

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70257-052-51?

    The NDC Packaged Code 70257-052-51 is assigned to a package of 1 vial, glass in 1 carton / 1 ml in 1 vial, glass (70257-052-11) of Hepagam B, a human prescription drug labeled by Saol Therapeutics Inc.. The product's dosage form is injection and is administered via intramuscular; intravenous form.

    Is NDC 70257-052 included in the NDC Directory?

    Yes, Hepagam B with product code 70257-052 is active and included in the NDC Directory. The product was first marketed by Saol Therapeutics Inc. on March 01, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 70257-052-51?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 70257-052-51?

    The 11-digit format is 70257005251. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-270257-052-515-4-270257-0052-51