Prescription drug · NDA
Biktarvy NDC 61958-2506
bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate · Bictegravir sodium 30 mg/1 + 2 more ingredients · Tablet · Oral · Gilead Sciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61958-2506-1 | 6195825060161958250601 | 30 TABLET in 1 BOTTLE, PLASTIC (61958-2506-1)Marketed from Oct 8, 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)
- Biktarvy
- Generic name (nonproprietary)
- bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
- Active ingredients
- Bictegravir sodium — 30 mg/1Emtricitabine — 120 mg/1Tenofovir alafenamide fumarate — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Gilead Sciences, Inc.NDC labeler code 61958
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210251
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)Nucleosides (Chemical structure)
- Identifiers
- Product ID 61958-2506_261dcc2a-c849-46b1-abf6-4981ed2c60bcSPL ID 261dcc2a-c849-46b1-abf6-4981ed2c60bc
- Pharmacologic class
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase 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
N461958250601followed by a unit qualifier and the quantityPackage 61958-2506-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 61958-2506
- What is NDC 61958-2506?
- 61958-2506 is the product NDC for Biktarvy, Bictegravir sodium 30 mg/1 + 2 more ingredients tablet, listed with the FDA by Gilead Sciences, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Biktarvy (Bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate).
- What is the active ingredient?
- Bictegravir sodium, Emtricitabine, Tenofovir alafenamide fumarate.
- Who is the labeler?
- Gilead Sciences, Inc., NDC labeler code 61958. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Biktarvy?
- 3 other product NDCs are listed under this name. See all Biktarvy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Biktarvy products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate | Bictegravir sodium 30 mg/1 + 2 more ingredients | TabletOral | Gilead Sciences, Inc. | 61958-2505 | 61958-2505-01 |
| Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate | Bictegravir sodium 50 mg/1 + 2 more ingredients | TabletOral | A-S Medication Solutions | 50090-6247 | 50090-6247-00 |
| Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate | Bictegravir sodium 50 mg/1 + 2 more ingredients | TabletOral | Gilead Sciences, Inc. | 61958-2501 | 61958-2501-0161958-2501-0261958-2501-03+1 more |
Other NDCs under NDA 210251
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 |
|---|---|---|---|---|
| Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate | Bictegravir sodium 50 mg/1 + 2 more ingredients | TabletOral | A-S Medication Solutions | 50090-6247 |
| Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate | Bictegravir sodium 50 mg/1 + 2 more ingredients | TabletOral | Gilead Sciences, Inc. | 61958-2501 |
| Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate | Bictegravir sodium 30 mg/1 + 2 more ingredients | TabletOral | Gilead Sciences, Inc. | 61958-2505 |