Truvada
- Product NDC
- 53808-0805
- 11-digit product format
- 538080805
- Labeler code
- 53808
- Product ID
- 53808-0805_877e3186-0c6f-47e4-b946-2fe53d80ef12
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- emtricitabine and tenofovir disoproxil fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- NDA021752
- Marketing category
- NDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 200 mg/1; 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#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53808-0805-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-56dd-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine/tenofovir disoproxil fumarate) tablets Initial U.S. Approval: 2004 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-0805-1 | Truvada | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| EMTRICITABINE | ACTIVE INGREDIENT | G70B4ETF4S | TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TENOFOVIR DISOPROXIL FUMARATE | ACTIVE INGREDIENT | OTT9J7900I | TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| emtricitabine | ACTIVE MOIETY | G70B4ETF4S | TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| tenofovir | ACTIVE MOIETY | 99YXE507IL | TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-0805 | TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20100415_d0b3d18b-7e5d-49ea-bcaf-8408414e8094.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | PSN | d0b3d18b-7e5d-49ea-bcaf-8408414e8094 | 1 |
| 639888 | Truvada 200 MG / 300 MG Oral Tablet | PSN | d0b3d18b-7e5d-49ea-bcaf-8408414e8094 | 1 |
| 639888 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Truvada] | SBD | d0b3d18b-7e5d-49ea-bcaf-8408414e8094 | 1 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | SCD | d0b3d18b-7e5d-49ea-bcaf-8408414e8094 | 1 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet | SY | d0b3d18b-7e5d-49ea-bcaf-8408414e8094 | 1 |
| 639888 | Truvada (emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral Tablet | SY | d0b3d18b-7e5d-49ea-bcaf-8408414e8094 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-0805-1 | 53808080501 | 30 in 1 BLISTER PACK | Historical |