Biktarvy
- Product NDC
- 50090-6247
- 11-digit product format
- 500906247
- Labeler code
- 50090
- Product ID
- 50090-6247_a3c4a0eb-71e8-4b35-9706-240874b78ee0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- NDA210251
- Marketing category
- NDA
- Marketing start
- 2018-02-07
- Substance
- BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
- Active strength
- 50; 200; 25 mg/1; mg/1; mg/1
- Pharmacologic classes
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Biktarvy
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BICTEGRAVIR SODIUM | 50 mg/1 |
| EMTRICITABINE | 200 mg/1 |
| TENOFOVIR ALAFENAMIDE FUMARATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4L5MP1Y7W7, G70B4ETF4S, FWF6Q91TZO |
| Rxcui | 1999667, 1999673 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-6247-0 | Biktarvy | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6247 | BIKTARVY (BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [A-S MEDICATION SOLUTIONS] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240501_0476d7eb-1024-4821-bbe7-abaacfda32a2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-6247-0 | 50090624700 | 30 TABLET in 1 BOTTLE, PLASTIC (50090-6247-0) | 30 tablet | 2022-11-28 | 0000-00-00 | No | No | Current |