Emtriva
- Product NDC
- 46014-0601
- 11-digit product format
- 460140601
- Labeler code
- 46014
- Product ID
- 46014-0601_1920b87b-ac14-4b51-ae82-9ccf51f1b00e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- emtricitabine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Excella GmbH
- Application
- NDA021500
- Marketing category
- NDA
- Marketing start
- 2003-07-02
- Marketing end
- 0000-00-00
- Substance
- EMTRICITABINE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 33cd1557-9629-1a35-1f2f-499cf7c608bc | Product name | 2 | 20260305 |
| 5f93de8c-a439-4aaa-862f-7cf2524cb240 | Product name | 3 | 20250812 |
| dc21b1c2-b0f7-7f56-b95f-dcd93cbc30a4 | Product name | 3 | 20240320 |
| c0c98dbe-5e23-74e9-f9fc-07af05f77d95 | Product name | 8 | 20240319 |
| 1cd1fd33-94db-4c45-bd26-82773ea350a3 | Product name | 2 | 20220317 |
| 14397d46-1c8c-bbf7-f4b7-5a7e59d3690f | Product name | 4 | 20220314 |
| a56d673d-fa42-4b0e-b5ce-e65a5eab34b7 | Product name | 1 | 20180911 |
| d1784558-3c5f-4d73-8a7c-051102bb6c92 | Product name | 1 | 20160405 |
| 7fd46899-3505-4ed4-b856-6b2509a76004 | Product name | 1 | 20151123 |
| 0583b5e6-2e6e-c94b-9ff6-81a81ba199de | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 46014-0601-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7c93-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use EMTRIVA safely and effectively. See full prescribing information for EMTRIVA. EMTRIVA (emtricitabine) capsule for oral use EMTRIVA (emtricitabine) solution for oral use Initial U.S. Approval: 2003 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 46014-0601-1 | Emtriva | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| emtricitabine | ACTIVE INGREDIENT | G70B4ETF4S | EMTRIVA (EMTRICITABINE) CAPSULE [EXCELLA GMBH] | 1 | |
| emtricitabine | ACTIVE MOIETY | G70B4ETF4S | EMTRIVA (EMTRICITABINE) CAPSULE [EXCELLA GMBH] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 46014-0601 | EMTRIVA (EMTRICITABINE) CAPSULE [EXCELLA GMBH] | 1 | Legacy NDC, 1 package rows | 20100628_946b680e-34e2-4789-8a9f-c00f851ad033.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 403875 | emtricitabine 200 MG Oral Capsule | PSN | 946b680e-34e2-4789-8a9f-c00f851ad033 | 1 |
| 404587 | Emtriva 200 MG Oral Capsule | PSN | 946b680e-34e2-4789-8a9f-c00f851ad033 | 1 |
| 404587 | emtricitabine 200 MG Oral Capsule [Emtriva] | SBD | 946b680e-34e2-4789-8a9f-c00f851ad033 | 1 |
| 403875 | emtricitabine 200 MG Oral Capsule | SCD | 946b680e-34e2-4789-8a9f-c00f851ad033 | 1 |
| 404587 | Emtriva 200 MG Oral Capsule | SY | 946b680e-34e2-4789-8a9f-c00f851ad033 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 46014-0601-1 | 46014060101 | 30 in 1 BOTTLE, PLASTIC | Historical |