Prescription drug · NDA
Descovy NDC 61958-2002
emtricitabine and tenofovir alafenamide · Emtricitabine 200 mg/1; Tenofovir alafenamide fumarate 25 mg/1 · Tablet · Oral · Gilead Sciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61958-2002-1 | 61958200201 | 30 TABLET in 1 BOTTLE, PLASTIC (61958-2002-1)Marketed from Apr 4, 2016 | |
| 61958-2002-2 | 61958200202 | 30 TABLET in 1 BLISTER PACK (61958-2002-2)Marketed from Jan 22, 2020 |
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)
- Descovy
- Generic name (nonproprietary)
- emtricitabine and tenofovir alafenamide
- Active ingredients
- Emtricitabine — 200 mg/1Tenofovir alafenamide fumarate — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Gilead Sciences, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208215
- 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 61958-2002_136e06f8-479d-4ecf-99f4-2a000ae61412SPL ID 136e06f8-479d-4ecf-99f4-2a000ae61412SPL set ID 06f66e98-e6ee-4538-9506-6c1282cc14c1RxCUI 1747691, 1747697, 2590641, 2590643UNII FWF6Q91TZO, G70B4ETF4S
- 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
N461958200201followed by a unit qualifier and the quantityPackage 61958-2002-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
HIV-1 Treatment ( 1.1 ): DESCOVY is a two-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and adolescent patients weighing at least 35 kg. for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg to less than 35 kg in combination with other antiretroviral agents, including darunavir and cobicistat but not other protease inhibitors that require a CYP3A inhibitor. HIV-1 PrEP ( 1.2 ): DESCOVY is indicated in at-risk adults and adolescents weighing at least 35 kg for…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 208215
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 |
|---|---|---|---|---|
| Descovyemtricitabine and tenofovir alafenamide | Emtricitabine 120 mg/1; Tenofovir alafenamide fumarate 15 mg/1 | TabletOral | Gilead Sciences, Inc. | 61958-2005 |