Prescription drug · ANDA
Darunavir NDC 59651-086
Darunavir propylene glycolate 800 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-086-30 | 59651008630 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-086-30)Marketed from Nov 28, 2023 |
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)
- Darunavir
- Generic name (nonproprietary)
- darunavir
- Active ingredients
- Darunavir propylene glycolate — 800 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210677
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)
- Identifiers
- Product ID 59651-086_2b5403e0-28fe-44ef-9b80-f754181ba220SPL ID 2b5403e0-28fe-44ef-9b80-f754181ba220SPL set ID 88910ad0-6dc3-4a47-8a6b-5c6ee79f2a93RxCUI 670026, 1359269UNII 6M6D7F3VC7
- 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
N459651008630followed by a unit qualifier and the quantityPackage 59651-0086-30. 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)
Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14) ] . Darunavir is a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older. Darunavir tablets must be co-administered with ritonavir (darunavir/ritonavir) and with other antiretroviral agents. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210677
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 propylene glycolate 800 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3910 |
| Darunavir | Darunavir propylene glycolate 600 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-085 |