PREZISTA
- Product NDC
- 53808-0773
- 11-digit product format
- 538080773
- Labeler code
- 53808
- Product ID
- 53808-0773_293699e1-d0c8-4d54-b360-e76b26b7da68
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- darunavir ethanolate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- NDA021976
- Marketing category
- NDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- DARUNAVIR ETHANOLATE
- Active strength
- 600 mg/1
- Pharmacologic classes
- HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53808-0773-1 | PREZISTA | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DARUNAVIR ETHANOLATE | ACTIVE INGREDIENT | 33O78XF0BW | PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| darunavir | ACTIVE MOIETY | YO603Y8113 | PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53808-0773 | PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | Legacy NDC, 1 package rows | 20100824_4cde01bb-230b-42d8-a9e1-4c7da1a01b76.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53808-0773-1 | 53808077301 | 30 in 1 BLISTER PACK | Historical |