Prescription drug · ANDA
Ritonavir NDC 65162-061
Ritonavir 100 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-061-06 | 65162006106 | 60 TABLET in 1 BOTTLE (65162-061-06)Marketed from Sep 21, 2018 | |
| 65162-061-32 | 65162006132 | 360 TABLET in 1 BOTTLE (65162-061-32)Marketed from Sep 21, 2018 |
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)
- Ritonavir
- Generic name (nonproprietary)
- ritonavir
- Active ingredients
- Ritonavir — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208890
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 1A2 Inducers (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)UDP Glucuronosyltransferases Inducers (Mechanism)
- Identifiers
- Product ID 65162-061_3ef0739f-9d04-4283-9bcd-fc21099f630cSPL ID 3ef0739f-9d04-4283-9bcd-fc21099f630cSPL set ID a32cb2e3-d4e5-4bbf-9d88-20b2b249e779RxCUI 900575UNII O3J8G9O825UPC 0365162061062
- Pharmacologic class
- Cytochrome P450 3A Inhibitor; Protease Inhibitor
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
N465162006106followed by a unit qualifier and the quantityPackage 65162-0061-06. 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)
Ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Ritonavir tablets are HIV protease inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
Excerpt only. Read the full label for complete information.
About NDC 65162-061
- What is NDC 65162-061?
- 65162-061 is the product NDC for Ritonavir, Ritonavir 100 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ritonavir.
- What is the active ingredient?
- Ritonavir.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ritonavir?
- 6 other product NDCs are listed under this name. See all Ritonavir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ritonavir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ritonavir | Ritonavir 100 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-420 | 60687-0420-25 |
| Ritonavir | Ritonavir 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2610 | 71335-2610-01 |
| Ritonavir | Ritonavir 100 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-687 | 65862-0687-0165862-0687-0565862-0687-30+1 more |
| Ritonavir | Ritonavir 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3898 | 68071-3898-03 |
| Ritonavir | Ritonavir 100 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-597 | 31722-0597-1231722-0597-30 |
| Ritonavir | Ritonavir 100 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5702 | 63629-5702-01 |