Prescription drug · ANDA
Atazanavir NDC 42385-920
Atazanavir sulfate 150 mg/1 · Capsule · Oral · Laurus Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42385-920-48 | 42385092048 | 10 BLISTER PACK in 1 CARTON (42385-920-48) / 6 CAPSULE in 1 BLISTER PACK (42385-920-06)Marketed from Apr 30, 2021 | |
| 42385-920-60 | 42385092060 | 60 CAPSULE in 1 BOTTLE (42385-920-60)Marketed from Apr 30, 2021 |
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 — 150 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Laurus Labs Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212579
- 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 42385-920_0e18774c-a32c-4961-9684-f5c6ffce64a1SPL ID 0e18774c-a32c-4961-9684-f5c6ffce64a1SPL set ID c98e40ec-8a2c-4f19-b1c3-c82f708c2490RxCUI 402246, 402247, 664741UNII 4MT4VIE29PUPC 0342385922301
- 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
N442385092048followed by a unit qualifier and the quantityPackage 42385-0920-48. 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 capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years of age and older weighing at least 15 kg. Limitations of Use: Atazanavir is 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 212579
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 200 mg/1 | CapsuleOral | Laurus Labs Limited | 42385-921 |
| Atazanavir | Atazanavir sulfate 300 mg/1 | CapsuleOral | Laurus Labs Limited | 42385-922 |