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  5. NDC Package Code: 16729-533-08 Dodex Injectable

NDC Package 16729-533-08 Dodex Injectable

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

Table of Contents

    1. Package Information
    2. 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:
16729-533-08
Package Description:
25 VIAL, MULTI-DOSE in 1 BOX / 1 mL in 1 VIAL, MULTI-DOSE
Product Code:
16729-533
Proprietary Name:
Dodex Injectable
Non-Proprietary Name:
Cyanocobalamin
Substance Name:
Cyanocobalamin
Usage Information:
Cyanocobalamin is indicated for vitamin B 12 deficiencies due to malabsorption which may be associated with the following conditions:  Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of pancreas or bowel Folic 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 B 12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin Injection, USP is also suitable for the vitamin B 12 absorption test ( Schilling test).
11-Digit NDC Billing Format:
16729053308
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2598453 - Dodex 1000 MCG/ML Injectable Solution
  • RxCUI: 2598453 - vitamin B12 1 MG/ML Injectable Solution [Dodex]
  • RxCUI: 2598453 - Dodex 1 MG/ML Injectable Solution
  • RxCUI: 2679170 - Dodex 1000 MCG in 1 ML Prefilled Syringe
  • RxCUI: 2679170 - 1 ML vitamin B12 1 MG/ML Prefilled Syringe [Dodex]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Accord Healthcare, 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.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • CYANOCOBALAMIN 1000 ug/mL
    • Pharmacologic Class(es):
  • Vitamin B 12 - [CS]
  • Vitamin B12 - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA083022
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-29-2022
    Listing Expiration Date:
    12-31-2025
    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 16729-533-08?

    The NDC Packaged Code 16729-533-08 is assigned to a package of 25 vial, multi-dose in 1 box / 1 ml in 1 vial, multi-dose of Dodex Injectable, a human prescription drug labeled by Accord Healthcare, Inc.. The product's dosage form is injection and is administered via intramuscular; subcutaneous form.

    Is NDC 16729-533 included in the NDC Directory?

    Yes, Dodex Injectable with product code 16729-533 is active and included in the NDC Directory. The product was first marketed by Accord Healthcare, Inc. on April 29, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 16729-533-08?

    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 16729-533-08?

    The 11-digit format is 16729053308. 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
    5-3-216729-533-085-4-216729-0533-08