Prescription drug · ANDA
darunavir (Darunavir 600 mg) NDC 76282-737
Darunavir hydrate 600 mg/1 · Tablet · Oral · EXELAN PHARMACEUTICALS INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-737-60 | 7628207376076282073760 | 60 TABLET in 1 BOTTLE (76282-737-60)Marketed from Jan 19, 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 600 mg
- Active ingredients
- Darunavir hydrate — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- EXELAN PHARMACEUTICALS INC.NDC labeler code 76282
- 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 76282-737_d4f6fed4-1a95-4d9a-8395-13818dedccd3SPL ID d4f6fed4-1a95-4d9a-8395-13818dedccd3SPL set ID ed977166-7ac0-4a8c-a10c-4b19a69403c0RxCUI 670026, 1359269UNII KPC4NRB25LUPC 0376282737607, 0376282738307
- 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
N476282073760followed by a unit qualifier and the quantityPackage 76282-0737-60. 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.
About NDC 76282-737
- What is NDC 76282-737?
- 76282-737 is the product NDC for darunavir (darunavir 600 mg), Darunavir hydrate 600 mg/1 tablet, listed with the FDA by EXELAN PHARMACEUTICALS INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- darunavir (Darunavir 600 mg).
- What is the active ingredient?
- Darunavir hydrate.
- Who is the labeler?
- EXELAN PHARMACEUTICALS INC., NDC labeler code 76282. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for darunavir?
- 23 other product NDCs are listed under this name. See all darunavir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other darunavir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Darunavir | Darunavir 600 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-088 | 31722-0088-60 |
| Darunavir | Darunavir 800 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-089 | 31722-0089-30 |
| Darunavir | Darunavir dihydrate 800 mg/1 | TabletOral | American Health Packaging | 60687-819 | 60687-0819-21 |
| Darunavir | Darunavir dihydrate 600 mg/1 | TabletOral | American Health Packaging | 60687-808 | 60687-0808-21 |
| Darunavir | Darunavir 600 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1745 | 70771-1745-0570771-1745-0670771-1745-08 |
| Darunavir | Darunavir 800 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1746 | 70771-1746-0370771-1746-0570771-1746-09 |
| Darunavir | Darunavir 600 mg/1 | Tablet, Film coatedOral | Viona Pharmaceuticals Inc | 72578-147 | 72578-0147-0572578-0147-1472578-0147-28 |
| Darunavir | Darunavir 800 mg/1 | Tablet, Film coatedOral | Viona Pharmaceuticals Inc | 72578-148 | 72578-0148-0572578-0148-0672578-0148-16 |
| darunavirdarunavir 800 mg | Darunavir hydrate 800 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-738 | 76282-0738-30 |
| Darunavir | Darunavir 600 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 60219-1144 | 60219-1144-06 |
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 | Darunavir dihydrate 600 mg/1 | TabletOral | American Health Packaging | 60687-808 |
| Darunavir | Darunavir dihydrate 800 mg/1 | TabletOral | American Health Packaging | 60687-819 |
| darunavirdarunavir 800 mg | Darunavir hydrate 800 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-738 |
| Darunavir 600 and 800 mgdarunavir | Darunavir dihydrate 800 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5686 |
| 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 |