Atripla
- Product NDC
- 15584-0101
- 11-digit product format
- 155840101
- Labeler code
- 15584
- Product ID
- 15584-0101_a618c51f-5e21-4c41-9607-417fd04ee8ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- efavirenz, emtricitabine, and tenofovir disoproxil fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Gilead Sciences, LLC
- Application
- NDA021937
- Marketing category
- NDA
- Marketing start
- 2006-07-20
- 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],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 15584-0101-1 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2b2a-f274-e053-dbdaa90a6471 | 2e97aa6d-09f7-46df-9499-63db7e9bac35 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 15584-0101-1 | EA - Each | 15584-0101 | 5b34cfc8-c719-423f-a9dc-90b874328b38 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
| 643070 | ATRIPLA 600 MG / 200 MG / 300 MG Oral Tablet | PSN | 2096a07e-8601-4bdc-ba5a-338a40cd02e9 | 3 |
| 643066 | efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 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 | 2096a07e-8601-4bdc-ba5a-338a40cd02e9 | 3 |
| 643070 | efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Atripla] | SBD | 076da359-b3d0-44f7-8c0e-662f5b7a8668 | 3 |
| 643070 | efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Atripla] | SBD | 2096a07e-8601-4bdc-ba5a-338a40cd02e9 | 3 |
| 643066 | efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | SCD | 076da359-b3d0-44f7-8c0e-662f5b7a8668 | 3 |
| 643066 | efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | SCD | 2096a07e-8601-4bdc-ba5a-338a40cd02e9 | 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 |
| 643070 | Atripla (efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral Tablet | SY | 2096a07e-8601-4bdc-ba5a-338a40cd02e9 | 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 |
| 643066 | efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet | SY | 2096a07e-8601-4bdc-ba5a-338a40cd02e9 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 15584-0101-1 | 15584010101 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15584-0101-1) | 2006-07-20 | 0000-00-00 | No | No | Current |