Stribild
- Product NDC
- 53808-0887
- 11-digit product format
- 538080887
- Labeler code
- 53808
- Product ID
- 53808-0887_ac228abb-ea52-4688-a175-8ad02b651fa0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- NDA203100
- Marketing category
- NDA
- Marketing start
- 2014-01-01
- Marketing end
- 0000-00-00
- Substance
- ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 150 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53808-0887-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1566-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use STRIBILD safely and effectively. See full prescribing information for STRIBILD. STRIBILD ® (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2012 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-0887-1 | Stribild | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-0887 | STRIBILD (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20141007_144067b2-0532-476a-996e-e4a0a9d09b05.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1306292 | elvitegravir 150 MG / cobicistat 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | PSN | 144067b2-0532-476a-996e-e4a0a9d09b05 | 1 |
| 1306298 | Stribild 150 MG / 150 MG / 200 MG / 300 MG Oral Tablet | PSN | 144067b2-0532-476a-996e-e4a0a9d09b05 | 1 |
| 1306298 | cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Stribild] | SBD | 144067b2-0532-476a-996e-e4a0a9d09b05 | 1 |
| 1306292 | cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | SCD | 144067b2-0532-476a-996e-e4a0a9d09b05 | 1 |
| 1306292 | cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet | SY | 144067b2-0532-476a-996e-e4a0a9d09b05 | 1 |
| 1306298 | Stribild (cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral Tablet | SY | 144067b2-0532-476a-996e-e4a0a9d09b05 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-0887-1 | 53808088701 | 30 in 1 BLISTER PACK | Historical |