Prescription drug · NDA
Stribild NDC 61958-1201
elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate · Elvitegravir 150 mg/1 + 3 more ingredients · Tablet, Film coated · Oral · Gilead Sciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61958-1201-1 | 61958120101 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1201-1)Marketed from Aug 27, 2012 |
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)
- Stribild
- Generic name (nonproprietary)
- elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
- Active ingredients
- Elvitegravir — 150 mg/1Cobicistat — 150 mg/1Emtricitabine — 200 mg/1Tenofovir disoproxil fumarate — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Gilead Sciences, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203100
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)HIV Integrase Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 1 Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)Nucleosides (Chemical structure)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 61958-1201_65c2d2eb-d180-41c3-b346-9cdc6e52d5edSPL ID 65c2d2eb-d180-41c3-b346-9cdc6e52d5edSPL set ID 74ae2a93-b267-444c-8f0f-a2a6522260eeRxCUI 1306292, 1306298UNII 4GDQ854U53, LW2E03M5PG, G70B4ETF4S, OTT9J7900I
- Pharmacologic class
- Cytochrome P450 3A Inhibitor; Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus Integrase Strand Transfer 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
N461958120101followed by a unit qualifier and the quantityPackage 61958-1201-01. 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)
STRIBILD ® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 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/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of STRIBILD [see Clinical Studies (14) ] . STRIBILD is a four-drug combination of elvitegravir, an HIV integrase strand transfer inhibitor (HIV-1 INSTI), cobicistat, a CYP3A inhibitor, a…
Excerpt only. Read the full label for complete information.