NDC Package 68083-449-25 Cyanocobalamin

Injection Intramuscular; Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

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:
68083-449-25
Package Description:
25 VIAL, MULTI-DOSE in 1 CARTON / 1 mL in 1 VIAL, MULTI-DOSE
Product Code:
Proprietary Name:
Cyanocobalamin
Non-Proprietary Name:
Cyanocobalamin
Substance Name:
Cyanocobalamin
Usage Information:
Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions:Addisonian (pernicious) anemiaGastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomyFish tapeworm infestationMalignancy of pancreas or bowelFolic acid deficiencyIt may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin.Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, haemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin Injection, USP is also suitable for the vitamin B12 absorption test (Schilling test).
11-Digit NDC Billing Format:
68083044925
NDC to RxNorm Crosswalk:
  • RxCUI: 309594 - cyanocobalamin 1000 MCG/ML Injectable Solution
  • RxCUI: 309594 - vitamin B12 1 MG/ML Injectable Solution
  • RxCUI: 309594 - cyanocobalamin 1 MG/ML Injectable Solution
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Gland Pharma Limited
    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.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA214390
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-24-2020
    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.

    Frequently Asked Questions

    What is NDC 68083-449-25?

    The NDC Packaged Code 68083-449-25 is assigned to a package of 25 vial, multi-dose in 1 carton / 1 ml in 1 vial, multi-dose of Cyanocobalamin, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is injection and is administered via intramuscular; subcutaneous form.

    Is NDC 68083-449 included in the NDC Directory?

    Yes, Cyanocobalamin with product code 68083-449 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on September 24, 2020 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 11-digit format for NDC 68083-449-25?

    The 11-digit format is 68083044925. 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
    5-3-268083-449-255-4-268083-0449-25