Prescription drug · ANDA
Darunavir NDC 70771-1745
Darunavir 600 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1745-5 | 70771174505 | 500 TABLET, FILM COATED in 1 BOTTLE (70771-1745-5)Marketed from May 1, 2024 | |
| 70771-1745-6 | 70771174506 | 60 TABLET, FILM COATED in 1 BOTTLE (70771-1745-6)Marketed from May 1, 2024 | |
| 70771-1745-8 | 70771174508 | 180 TABLET, FILM COATED in 1 BOTTLE (70771-1745-8)Marketed from May 1, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Darunavir
- Generic name (nonproprietary)
- darunavir
- Active ingredients
- Darunavir — 600 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214085
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)
- Identifiers
- Product ID 70771-1745_1b288e91-dedb-465d-8c45-eb464dc72e89SPL ID 1b288e91-dedb-465d-8c45-eb464dc72e89SPL set ID 6a029063-b14c-4eee-9958-0d9eecb27726RxCUI 670026, 1359269UNII YO603Y8113UPC 0372578148065
- 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
N470771174505followed by a unit qualifier and the quantityPackage 70771-1745-05. 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 .
Other NDCs under ANDA 214085
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 |
|---|---|---|---|---|
| Darunavir | Darunavir 600 mg/1 | Tablet, Film coatedOral | Viona Pharmaceuticals Inc | 72578-147 |
| Darunavir | Darunavir 800 mg/1 | Tablet, Film coatedOral | Viona Pharmaceuticals Inc | 72578-148 |
| Darunavir | Darunavir 800 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1746 |