Prescription drug · NDA
Ribavirin NDC 68682-019
Ribavirin 6 g/1 · Powder, For solution · Respiratory (Inhalation) · Oceanside Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68682-019-01 | 68682001901 | 1 VIAL, GLASS in 1 CARTON (68682-019-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, GLASSMarketed from Aug 27, 2019 | |
| 68682-019-06 | 68682001906 | 4 VIAL, GLASS in 1 CARTON (68682-019-06) / 1 POWDER, FOR SOLUTION in 1 VIAL, GLASSMarketed from Apr 14, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Ribavirin
- Generic name (nonproprietary)
- ribavirin
- Active ingredients
- Ribavirin — 6 g/1
- Dosage form
- Powder, For solution
- Route
- Respiratory (Inhalation)
- Labeler
- Oceanside Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018859
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Analog (EXT)
- Identifiers
- Product ID 68682-019_6b3c6edc-c735-46e0-9b31-fac85dda0992SPL ID 6b3c6edc-c735-46e0-9b31-fac85dda0992SPL set ID d74aa4f3-0b7d-480d-b5bf-41ddf808b260RxCUI 312818UNII 49717AWG6K
- Pharmacologic class
- Nucleoside Analog Antiviral
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.
- NDC on a medical claim
N468682001901followed by a unit qualifier and the quantityPackage 68682-0019-01. 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)
INDICATIONS AND USAGE Ribavirin for Inhalation Solution, USP is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to RSV. Treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy. Only severe RSV lower respiratory tract infection should be treated with Ribavirin for Inhalation Solution, USP. The vast majority of infants and children with RSV infection have disease that is mild, self-limited, and does not require hospitalization or antiviral treatment. Many children with mild lower respiratory tract involvement will require shorter hospitalization than would be require…
Excerpt only. Read the full label for complete information.