Prescription drug · NDA
Evotaz NDC 0003-3641
atazanavir and cobicistat · Atazanavir sulfate 300 mg/1; Cobicistat 150 mg/1 · Tablet · Oral · E.R. Squibb & Sons, L.L.C.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0003-3641-11 | 00003364111 | 30 TABLET in 1 BOTTLE (0003-3641-11)Marketed from Jan 29, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Evotaz
- Generic name (nonproprietary)
- atazanavir and cobicistat
- Active ingredients
- Atazanavir sulfate — 300 mg/1Cobicistat — 150 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- E.R. Squibb & Sons, L.L.C.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206353
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)UDP Glucuronosyltransferases Inhibitors (Mechanism)UGT1A1 Inhibitors (Mechanism)
- Identifiers
- Product ID 0003-3641_fa642c67-5a9e-4136-a141-64e1236f6a0fSPL ID fa642c67-5a9e-4136-a141-64e1236f6a0fSPL set ID 83db29d7-5d85-49d6-8cb6-740473365cf8RxCUI 1601654, 1601660UNII 4MT4VIE29P, LW2E03M5PG
- 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
N400003364111followed by a unit qualifier and the quantityPackage 00003-3641-11. 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)
EVOTAZ is a two-drug combination of atazanavir, a human immunodeficiency virus (HIV-1) protease inhibitor, and cobicistat, a CYP3A inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults and pediatric patients weighing at least 35 kg. (1) Limitations of Use Use of EVOTAZ in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions. (1) 1.1 Indications EVOTAZ ® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in the following populations [see Dosage and Administration (2.2 , 2.3) ]…
Excerpt only. Read the full label for complete information.
- openFDA data updated
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