Prescription drug · ANDA
Ribavirin NDC 65862-207
Ribavirin 200 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-207-05 | 65862020705 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-207-05)Marketed from Sep 17, 2009 | |
| 65862-207-68 | 65862020768 | 168 TABLET, FILM COATED in 1 BOTTLE (65862-207-68)Marketed from Sep 17, 2009 |
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 — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079111
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Analog (EXT)
- Identifiers
- Product ID 65862-207_683ccd3f-445b-4488-b14c-8d5810d8633aSPL ID 683ccd3f-445b-4488-b14c-8d5810d8633aSPL set ID eee304d0-c2ea-44f4-97d9-92a414d31b6cRxCUI 248109UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465862020705followed by a unit qualifier and the quantityPackage 65862-0207-05. 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)
Ribavirin tablets in combination with PEGASYS ® (peginterferon alfa-2a) are indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha. The following points should be considered when initiating ribavirin tablets combination therapy with PEGASYS ® : This indication is based on clinical trials of combination therapy in patients with CHC and compensated liver disease, some of whom had histological evidence of cirrhosis (Child-Pugh class A), and in adult patients with clinically stable HIV disease and CD4 count greater than 100 cells/mm 3 . This indic…
Excerpt only. Read the full label for complete information.
About NDC 65862-207
- What is NDC 65862-207?
- 65862-207 is the product NDC for Ribavirin, Ribavirin 200 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ribavirin.
- What is the active ingredient?
- Ribavirin.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ribavirin?
- 2 other product NDCs are listed under this name. See all Ribavirin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ribavirin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ribavirin | Ribavirin 6 g/1 | Powder, For solutionRespiratory (Inhalation) | Oceanside Pharmaceuticals | 68682-019 | 68682-0019-0168682-0019-06 |
| Ribavirin | Ribavirin 200 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-290 | 65862-0290-0565862-0290-1865862-0290-42+3 more |