Prescription drug · NDA
Reyataz (atazanavir) NDC 0003-3638
Atazanavir sulfate 50 mg/1 · Powder · Oral · E.R. Squibb & Sons, L.L.C.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0003-3638-10 | 00003363810 | 30 PACKET in 1 CARTON (0003-3638-10) / 1 POWDER in 1 PACKETMarketed from Dec 19, 2014 |
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)
- Reyataz
- Generic name (nonproprietary)
- atazanavir
- Active ingredients
- Atazanavir sulfate — 50 mg/1
- Dosage form
- Powder
- Route
- Oral
- Labeler
- E.R. Squibb & Sons, L.L.C.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206352
- 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 0003-3638_510c2d51-4943-401c-a008-ea22f61c6938SPL ID 510c2d51-4943-401c-a008-ea22f61c6938SPL set ID 165cff62-b284-4a27-a65d-9ec8a5bfcdd8RxCUI 402093, 402094, 402246, 402247, 664741, 664743, 1598985, 1598989UNII 4MT4VIE29PUPC 0300033624120, 0300033622126
- 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
N400003363810followed by a unit qualifier and the quantityPackage 00003-3638-10. 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 .
Indications (excerpt from the label)
REYATAZ ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: • REYATAZ 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 REYATAZ with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4) ] . REYATAZ is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults…
Excerpt only. Read the full label for complete information.