Cnj-016 Injection
NDC Package 60492-0173-2
Package Information
Cnj-016 (vaccinia immune globulin intravenous (human)) injection is cNJ-016® [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV) is indicated for the treatment and/or modification of the following conditions:•Eczema vaccinatum•Progressive vaccinia•Severe generalized vaccinia•Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions•Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard.Exercise caution when using VIGIV in the treatment of patients having complication due to vaccinia vaccination that include concomitant vaccinia keratitis, since a single study in rabbits has demonstrated increased corneal scarring upon intramuscular vaccinia immune globulin administration in vaccinia keratitis (1).VIGIV is not considered to be effective in the treatment of postvaccinial encephalitis. This formulation utilizes a injection delivery system. Marketed by Emergent Biosolutions Canada Inc., this product is identified by NDC 60492-0173 and is authorized under FDA application BLA125109.
Identification & Billing
- RxCUI: 1922329 - Human vaccinia immune globulin 50,000 UNT in 20 ML Injection
- RxCUI: 1922329 - 20 ML human vaccinia immune globulin 2500 UNT/ML Injection
- RxCUI: 1922329 - Human vaccinia immune globulin 50,000 UNT per 20 ML Injection
- RxCUI: 1922334 - CNJ-016 50,000 UNT in 20 ML Injection
- RxCUI: 1922334 - 20 ML human vaccinia immune globulin 2500 UNT/ML Injection [CNJ-016]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 60492 - Emergent Biosolutions Canada Inc.
- 60492-0173 - Cnj-016
- 60492-0173-2 - 24 VIAL, SINGLE-USE in 1 CARTON / 12 mL in 1 VIAL, SINGLE-USE (60492-0173-1)
- 60492-0173 - Cnj-016
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 full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 60492-0173-2 identifies a specific commercial package of 24 vial, single-use in 1 carton / 12 ml in 1 vial, single-use (60492-0173-1) of Cnj-016, a human prescription drug labeled by Emergent Biosolutions Canada Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection is formulated for intravenous use and contains human vaccinia virus immune globulin as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Emergent Biosolutions Canada Inc. on May 02, 2005. The current certification is valid through December 31, 2027.
How is this Emergent Biosolutions Canada Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 60492017302. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
