ODEFSEY
- Product NDC
- 61958-2101
- 11-digit product format
- 619582101
- Labeler code
- 61958
- Product ID
- 61958-2101_130b8bbc-f660-40ff-831c-139734f90b99
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Gilead Sciences, Inc.
- Application
- NDA208351
- Marketing category
- NDA
- Marketing start
- 2016-03-01
- Substance
- EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
- Active strength
- 200; 25; 25 mg/1; mg/1; mg/1
- Pharmacologic classes
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], 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
- ODEFSEY
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EMTRICITABINE | 200 mg/1 |
| RILPIVIRINE HYDROCHLORIDE | 25 mg/1 |
| TENOFOVIR ALAFENAMIDE FUMARATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G70B4ETF4S, 212WAX8KDD, FWF6Q91TZO |
| Rxcui | 1741733, 1741739 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 61958-2101-1 | 2025-02-11 | C162847 | 48780-1 | ab0e2407-2f96-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use ODEFSEY safely and effectively. See full prescribing information for ODEFSEY. ODEFSEY ® (emtricitabine, rilpivirine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2016 |
| 61958-2101-1 | 2025-01-30 | C162847 | 48780-1 | ab0e2407-2f96-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use ODEFSEY safely and effectively. See full prescribing information for ODEFSEY. ODEFSEY ® (emtricitabine, rilpivirine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2016 |
| 61958-2101-1 | 2023-02-06 | C162847 | 48780-1 | ab0e2407-2f96-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use ODEFSEY safely and effectively. See full prescribing information for ODEFSEY. ODEFSEY ® (emtricitabine, rilpivirine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2016 |
| 61958-2101-1 | 2023-01-30 | C162847 | 48780-1 | ab0e2407-2f96-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use ODEFSEY safely and effectively. See full prescribing information for ODEFSEY. ODEFSEY ® (emtricitabine, rilpivirine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2016 |
| 61958-2101-1 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2f96-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use ODEFSEY safely and effectively. See full prescribing information for ODEFSEY. ODEFSEY ® (emtricitabine, rilpivirine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2016 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61958-2101-1 | ODEFSEY | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61958-2101 | ODEFSEY (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR ALAFENAMIDE) TABLET [GILEAD SCIENCES, INC.] | 12 | Current NDC, Legacy NDC, 1 package rows | 20250306_ea3b9ec8-e04a-412c-8b3f-e5cbc7e641d5.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 |
|---|
| 61958-2101-1 | 61958210101 | 30 TABLET in 1 BOTTLE, PLASTIC (61958-2101-1) | 30 tablet | 2016-03-01 | 0000-00-00 | No | No | Current |