Prescription drug · ANDA
Darunavir NDC 60687-819
Darunavir dihydrate 800 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-819-21 | 60687081921 | 30 BLISTER PACK in 1 CARTON (60687-819-21) / 1 TABLET in 1 BLISTER PACK (60687-819-11)Marketed from Jun 25, 2024 |
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 dihydrate — 800 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206288
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)
- Identifiers
- Product ID 60687-819_5b8bf473-5fd1-7962-e063-6394a90a405fSPL ID 5b8bf473-5fd1-7962-e063-6394a90a405f
- 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
N460687081921followed by a unit qualifier and the quantityPackage 60687-0819-21. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 206288
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 600 and 800 mgdarunavir | Darunavir hydrate 800 mg/1 | TabletOral | Cipla USA Inc. | 69097-244 |
| Darunavir 600 and 800 mgdarunavir | Darunavir hydrate 600 mg/1 | TabletOral | Cipla USA Inc. | 69097-248 |
| Darunavir | Darunavir dihydrate 600 mg/1 | TabletOral | American Health Packaging | 60687-808 |
| Darunavir 600 and 800 mgdarunavir | Darunavir dihydrate 800 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5686 |
| darunavirdarunavir 600 mg | Darunavir hydrate 600 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-737 |
| darunavirdarunavir 800 mg | Darunavir hydrate 800 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-738 |