Prescription drug · BLA
Cnj-016 NDC 60492-0173
vaccinia immune globulin intravenous (human) · Human vaccinia virus immune globulin 1 [iU]/mL · Injection · Intravenous · Emergent BioSolutions Canada Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60492-0173-2 | 60492017302 | 24 VIAL, SINGLE-USE in 1 CARTON (60492-0173-2) / 12 mL in 1 VIAL, SINGLE-USE (60492-0173-1)Marketed from Jan 12, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cnj-016
- Generic name (nonproprietary)
- vaccinia immune globulin intravenous (human)
- Active ingredients
- Human vaccinia virus immune globulin — 1 [iU]/mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125109
- Marketing start
- Listing expires
- Other FDA classes
- Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)Virus Neutralization (Mechanism)Virus-specific Hyperimmune Globulins (EXT)
- Identifiers
- Product ID 60492-0173_ad4abcf6-88ca-41ff-a0f0-75692c8d517cSPL ID ad4abcf6-88ca-41ff-a0f0-75692c8d517cSPL set ID a4f9f620-e6e4-4a03-a9a7-79007c8c2cfeRxCUI 1922329, 1922334UNII 7UB4J759TDUPC 0360492017321
- Pharmacologic class
- Human Immunoglobulin G
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N460492017302followed by a unit qualifier and the quantityPackage 60492-0173-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
VIGIV (vaccinia immune globulin intravenous, human) 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. VIGIV is not considered to be effective …
Excerpt only. Read the full label for complete information.