Intelence
- Product NDC
- 53808-0787
- 11-digit product format
- 538080787
- Labeler code
- 53808
- Product ID
- 53808-0787_4eae84af-ae77-47c6-ade9-e78a26d33b59
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etravirine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- NDA022187
- Marketing category
- NDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- ETRAVIRINE
- Active strength
- 100 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]
- 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 |
|---|---|---|---|
| 08bcdf9c-0f44-79ee-51ca-e7f77478ea2e | Product name | 2 | 20230112 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53808-0787-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0051-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use INTELENCE ® safely and effectively. See full prescribing information for INTELENCE ® . INTELENCE ® (etravirine) [Tablets] Initial U.S. Approval – 2008 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-0787-1 | Intelence | 30 in 1 BLISTER PACK | TABLET | 30 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ETRAVIRINE | ACTIVE INGREDIENT | 0C50HW4FO1 | INTELENCE (ETRAVIRINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| etravirine | ACTIVE MOIETY | 0C50HW4FO1 | INTELENCE (ETRAVIRINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | INTELENCE (ETRAVIRINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | INTELENCE (ETRAVIRINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | INTELENCE (ETRAVIRINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | INTELENCE (ETRAVIRINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | INTELENCE (ETRAVIRINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | INTELENCE (ETRAVIRINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-0787 | INTELENCE (ETRAVIRINE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | Legacy NDC, 1 package rows | 20100809_1b5a2dc7-0570-4977-876d-88b4176844a1.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 754761 | etravirine 100 MG Oral Tablet | PSN | 1b5a2dc7-0570-4977-876d-88b4176844a1 | 2 |
| 758555 | INTELENCE 100 MG Oral Tablet | PSN | 1b5a2dc7-0570-4977-876d-88b4176844a1 | 2 |
| 758555 | etravirine 100 MG Oral Tablet [Intelence] | SBD | 1b5a2dc7-0570-4977-876d-88b4176844a1 | 2 |
| 754761 | etravirine 100 MG Oral Tablet | SCD | 1b5a2dc7-0570-4977-876d-88b4176844a1 | 2 |
| 758555 | Intelence 100 MG Oral Tablet | SY | 1b5a2dc7-0570-4977-876d-88b4176844a1 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-0787-1 | 53808078701 | 30 in 1 BLISTER PACK | Historical |