Prescription drug · ANDA
Darunavir 600 and 800 mg (Darunavir) NDC 63629-5686
Darunavir dihydrate 800 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-5686-1 | 6362956860163629568601 | 15 TABLET in 1 BOTTLE (63629-5686-1)Marketed from Jun 5, 2025 |
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 600 and 800 mg
- Generic name (nonproprietary)
- darunavir
- Active ingredients
- Darunavir dihydrate — 800 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- 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 63629-5686_290dd3c3-c6b7-415f-99b3-680080281b30SPL ID 290dd3c3-c6b7-415f-99b3-680080281b30SPL set ID bf99d8b8-c4e0-4cb4-924e-8cdcfd8d1aa1RxCUI 1359269UNII KPC4NRB25L
- 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
N463629568601followed by a unit qualifier and the quantityPackage 63629-5686-01. 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 63629-5686
- What is NDC 63629-5686?
- 63629-5686 is the product NDC for Darunavir 600 and 800 mg (darunavir), Darunavir dihydrate 800 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Darunavir 600 and 800 mg (Darunavir).
- What is the active ingredient?
- Darunavir dihydrate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 600 and 800 mg?
- 2 other product NDCs are listed under this name. See all Darunavir 600 and 800 mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Darunavir 600 and 800 mg 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 600 and 800 mgdarunavir | Darunavir hydrate 800 mg/1 | TabletOral | Cipla USA Inc. | 69097-244 | 69097-0244-02 |
| Darunavir 600 and 800 mgdarunavir | Darunavir hydrate 600 mg/1 | TabletOral | Cipla USA Inc. | 69097-248 | 69097-0248-03 |
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 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 |
| 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 |