Symtuza
- Product NDC
- 59676-800
- 11-digit product format
- 596760800
- Labeler code
- 59676
- Product ID
- 59676-800_a8468da1-a6e7-4a14-a108-23915ccaeee8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Janssen Products LP
- Application
- NDA210455
- Marketing category
- NDA
- Marketing start
- 2018-07-17
- Substance
- COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE
- Active strength
- 150; 800; 200; 10 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], 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], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Symtuza
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COBICISTAT | 150 mg/1 |
| DARUNAVIR | 800 mg/1 |
| EMTRICITABINE | 200 mg/1 |
| TENOFOVIR ALAFENAMIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LW2E03M5PG, YO603Y8113, G70B4ETF4S, EL9943AG5J |
| Rxcui | 2049671, 2049677 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 59676-800-30 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3409-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use SYMTUZA safely and effectively. See full prescribing information for SYMTUZA. SYMTUZA ® (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018 |
| 59676-800-99 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3409-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use SYMTUZA safely and effectively. See full prescribing information for SYMTUZA. SYMTUZA ® (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59676-800-30 | Symtuza | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 23 |
| 59676-800-99 | Symtuza | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59676-800 | SYMTUZA (DARUNAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE) TABLET, FILM COATED [JANSSEN PRODUCTS LP] | 22 | Current NDC, Legacy NDC, 2 package rows | 20240724_85a17d00-6b7c-41ea-a6b3-5ad924820dab.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59676-800-30 | 59676080030 | 30 TABLET, FILM COATED in 1 BOTTLE (59676-800-30) | 2018-07-17 | 0000-00-00 | No | No | Current |
| 59676-800-99 | 59676080099 | 30 TABLET, FILM COATED in 1 BOTTLE (59676-800-99) | 2018-07-17 | 0000-00-00 | Yes | No | Current |