NDC Package 16729-533-08 Dodex Injectable

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:
Proprietary Name:
Dodex Injectable
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.
Labeler Name:
Accord Healthcare, Inc.
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
End Marketing Date:
01-17-2025
Listing Expiration Date:
01-17-2025
Exclude Flag:
D
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.

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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 16729-533-08 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
16729053308J3420Vitamin b12 injection1000 MCG125125

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Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
16729-533-031 VIAL, MULTI-DOSE in 1 BOX / 10 mL in 1 VIAL, MULTI-DOSE
16729-533-101 VIAL, MULTI-DOSE in 1 BOX / 30 mL in 1 VIAL, MULTI-DOSE
16729-533-631 VIAL, MULTI-DOSE in 1 BOX / 1 mL in 1 VIAL, MULTI-DOSE

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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, labeled by Accord Healthcare, Inc.. The product's dosage form is and is administered via form.

Is NDC 16729-533 included in the NDC Directory?

No, Dodex Injectable with product code 16729-533 is excluded from the NDC Directory because it was discontinued by the manufacturer. 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 January 17, 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