Atripla
- Product NDC
- 53808-0208
- 11-digit product format
- 538080208
- Labeler code
- 53808
- Product ID
- 53808-0208_20fe8a0b-95db-4d4c-80e2-54a9126ab845
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- efavirenz, emtricitabine, and tenofovir disoproxil fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- DOH CENTRAL PHARMACY
- Application
- NDA021937
- Marketing category
- NDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 600 mg/1; mg/1; mg/1
- Pharmacologic classes
- Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 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 |
|---|---|---|---|---|---|
| 53808-0208-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8ec3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ATRIPLA safely and effectively. See full prescribing information for ATRIPLA. ATRIPLA ® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets Initial U.S. Approval: 2006 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-0208-1 | Atripla | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-0208 | ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [DOH CENTRAL PHARMACY] | 3 | Legacy NDC, 1 package rows | 20170203_076da359-b3d0-44f7-8c0e-662f5b7a8668.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 643070 | ATRIPLA 600 MG / 200 MG / 300 MG Oral Tablet | PSN | 076da359-b3d0-44f7-8c0e-662f5b7a8668 | 3 |
| 643066 | efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | PSN | 076da359-b3d0-44f7-8c0e-662f5b7a8668 | 3 |
| 643070 | efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Atripla] | SBD | 076da359-b3d0-44f7-8c0e-662f5b7a8668 | 3 |
| 643066 | efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | SCD | 076da359-b3d0-44f7-8c0e-662f5b7a8668 | 3 |
| 643070 | Atripla (efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral Tablet | SY | 076da359-b3d0-44f7-8c0e-662f5b7a8668 | 3 |
| 643066 | efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet | SY | 076da359-b3d0-44f7-8c0e-662f5b7a8668 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-0208-1 | 53808020801 | 30 in 1 BLISTER PACK | Historical |