Prescription drug · NDA
Biktarvy NDC 50090-6247
bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate · Bictegravir sodium 50 mg/1 + 2 more ingredients · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6247-0 | 50090624700 | 30 TABLET in 1 BOTTLE, PLASTIC (50090-6247-0)Marketed from Nov 28, 2022 |
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 — 50 mg/1Emtricitabine — 200 mg/1Tenofovir alafenamide fumarate — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- 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 50090-6247_a3c4a0eb-71e8-4b35-9706-240874b78ee0SPL ID a3c4a0eb-71e8-4b35-9706-240874b78ee0SPL set ID 0476d7eb-1024-4821-bbe7-abaacfda32a2RxCUI 1999667, 1999673UNII 4L5MP1Y7W7, G70B4ETF4S, FWF6Q91TZO
- 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
N450090624700followed by a unit qualifier and the quantityPackage 50090-6247-00. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg: who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. BIKTARVY is a three-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-…
Excerpt only. Read the full label for complete information.
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 30 mg/1 + 2 more ingredients | TabletOral | Gilead Sciences, Inc. | 61958-2506 |
| Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate | Bictegravir sodium 30 mg/1 + 2 more ingredients | TabletOral | Gilead Sciences, Inc. | 61958-2505 |
| Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate | Bictegravir sodium 50 mg/1 + 2 more ingredients | TabletOral | Gilead Sciences, Inc. | 61958-2501 |