Prescription drug · ANDA
Atazanavir NDC 31722-654
Atazanavir sulfate 200 mg/1 · Capsule · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-654-10 | 31722065410 | 1000 CAPSULE in 1 BOTTLE (31722-654-10)Marketed from Feb 7, 2022 | |
| 31722-654-31 | 31722065431 | 100 BLISTER PACK in 1 CARTON (31722-654-31) / 10 CAPSULE in 1 BLISTER PACKMarketed from Feb 7, 2022 | |
| 31722-654-60 | 31722065460 | 60 CAPSULE in 1 BOTTLE (31722-654-60)Marketed from Feb 7, 2022 |
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
- Generic name (nonproprietary)
- atazanavir
- Active ingredients
- Atazanavir sulfate — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212278
- 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 31722-654_30891c38-5d64-7df7-e063-6394a90ae762SPL ID 30891c38-5d64-7df7-e063-6394a90ae762SPL set ID 8a0c609f-e296-4925-a35c-e93a04467655RxCUI 402246, 402247, 664741UNII 4MT4VIE29PUPC 0331722654609, 0331722653602, 0331722655309
- 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
N431722065410followed by a unit qualifier and the quantityPackage 31722-0654-10. 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)
Atazanavir capsules are 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 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 with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology ( 12.4 )] . Atazanavir capsules are a protease inhibitor indicated for use in combination with other antiretroviral agents for the treat…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212278
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 | Atazanavir sulfate 150 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-653 |
| Atazanavir | Atazanavir sulfate 300 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-655 |