Prescription drug · ANDA
Atazanavir Sulfate (atazanavir) NDC 65862-710
Atazanavir sulfate 100 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-710-03 | 65862071003 | 3 BLISTER PACK in 1 CARTON (65862-710-03) / 10 CAPSULE in 1 BLISTER PACK (65862-710-10)Marketed from Jun 25, 2018 | |
| 65862-710-05 | 65862071005 | 500 CAPSULE in 1 BOTTLE (65862-710-05)Marketed from Jun 25, 2018 | |
| 65862-710-60 | 65862071060 | 60 CAPSULE in 1 BOTTLE (65862-710-60)Marketed from Jun 25, 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)
- Atazanavir Sulfate
- Generic name (nonproprietary)
- atazanavir
- Active ingredients
- Atazanavir sulfate — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204806
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)UDP Glucuronosyltransferases Inhibitors (Mechanism)UGT1A1 Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-710_8f8c56e0-40ee-4643-88f7-d3571ff5a409SPL ID 8f8c56e0-40ee-4643-88f7-d3571ff5a409SPL set ID 7fbea274-d6b5-4faa-bbf0-05fefab42114RxCUI 402245, 402246, 402247, 664741UNII 4MT4VIE29P
- Pharmacologic class
- 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
N465862071003followed by a unit qualifier and the quantityPackage 65862-0710-03. 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 .
Indications (excerpt from the label)
Atazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4) ]. Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4) ] . Atazanavir capsule is a protease inhibitor indicated for use in combination with other antiretroviral agents for th…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204806
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Atazanavir Sulfateatazanavir | Atazanavir sulfate 150 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-711 |
| Atazanavir Sulfateatazanavir | Atazanavir sulfate 200 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-712 |
| Atazanavir Sulfateatazanavir | Atazanavir sulfate 300 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-713 |