PREZISTA
- Product NDC
- 59676-563
- 11-digit product format
- 596760563
- Labeler code
- 59676
- Product ID
- 59676-563_3d80bc62-24ac-c092-e063-6394a90a7bba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- darunavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Janssen Products LP
- Application
- NDA021976
- Marketing category
- NDA
- Marketing start
- 2009-01-14
- Substance
- DARUNAVIR ETHANOLATE
- Active strength
- 75 mg/1
- Pharmacologic classes
- Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PREZISTA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DARUNAVIR ETHANOLATE | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33O78XF0BW |
| Rxcui | 670026, 794610, 831868, 831870, 850455, 850457, 1236628, 1236632, 1359269, 1359271 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59676-563-01 | PREZISTA | 480 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 480 | | 58 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| darunavir ethanolate | ACTIVE INGREDIENT | 33O78XF0BW | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| darunavir | ACTIVE MOIETY | YO603Y8113 | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| METHYLPARABEN SODIUM | INACTIVE INGREDIENT | CR6K9C2NHK | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| polyethylene glycol 3350 | INACTIVE INGREDIENT | G2M7P15E5P | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| STRAWBERRY | INACTIVE INGREDIENT | 4J2TY8Y81V | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 31 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59676-563 | PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | 57 | Current NDC, Legacy NDC, 1 package rows | 20240724_814301f9-c990-46a5-b481-2879a521a16f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59676-563-01 | 59676056301 | 480 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-563-01) | 2009-01-14 | 0000-00-00 | No | No | Current |