Home NDC 59676-566 PREZISTA
Product NDC 59676-566
11-digit product format 596760566
Labeler code 59676
Product ID 59676-566_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 2012-11-09
Substance DARUNAVIR ETHANOLATE
Active strength 800 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021976-001 PREZISTA DARUNAVIR 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 N021976-002 PREZISTA DARUNAVIR 600MG TABLET / ORAL AB RLD 2008-02-25 N021976-003 PREZISTA DARUNAVIR 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-10-21 N021976-004 PREZISTA DARUNAVIR 75MG TABLET / ORAL AB RLD 2008-12-18 N021976-005 PREZISTA DARUNAVIR 150MG TABLET / ORAL AB RLD 2008-12-18 N021976-006 PREZISTA DARUNAVIR 800MG TABLET / ORAL AB RLD, RS 2012-11-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021976-001 7700645 2026-12-26 Drug substance, Drug product N021976-001 7700645*PED 2027-06-26 Pediatric extension N021976-002 7700645 2026-12-26 Drug substance, Drug product N021976-002 7700645*PED 2027-06-26 Pediatric extension N021976-003 7700645 2026-12-26 Drug substance, Drug product N021976-003 7700645*PED 2027-06-26 Pediatric extension N021976-004 7700645 2026-12-26 Drug substance, Drug product N021976-004 7700645*PED 2027-06-26 Pediatric extension N021976-005 7700645 2026-12-26 Drug substance, Drug product N021976-005 7700645*PED 2027-06-26 Pediatric extension N021976-006 7700645 2026-12-26 Drug substance, Drug product N021976-006 7700645*PED 2027-06-26 Pediatric extension
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 7 · 246 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021976-001 PREZISTA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-002 PREZISTA 600MG TABLET / ORAL AB RLD 2008-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-003 PREZISTA 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-004 PREZISTA 75MG TABLET / ORAL AB RLD 2008-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-005 PREZISTA 150MG TABLET / ORAL AB RLD 2008-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-006 PREZISTA 800MG TABLET / ORAL AB RLD, RS 2012-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-001 PREZISTA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-002 PREZISTA 600MG TABLET / ORAL AB RLD 2008-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-003 PREZISTA 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-004 PREZISTA 75MG TABLET / ORAL AB RLD 2008-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-005 PREZISTA 150MG TABLET / ORAL AB RLD 2008-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-006 PREZISTA 800MG TABLET / ORAL AB RLD, RS 2012-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021976-001 PREZISTA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-002 PREZISTA 600MG TABLET / ORAL AB RLD 2008-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-003 PREZISTA 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-004 PREZISTA 75MG TABLET / ORAL AB RLD 2008-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-005 PREZISTA 150MG TABLET / ORAL AB RLD 2008-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-006 PREZISTA 800MG TABLET / ORAL AB RLD, RS 2012-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-001 PREZISTA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-002 PREZISTA 600MG TABLET / ORAL AB RLD 2008-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-003 PREZISTA 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-004 PREZISTA 75MG TABLET / ORAL RLD 2008-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-005 PREZISTA 150MG TABLET / ORAL RLD 2008-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-006 PREZISTA 800MG TABLET / ORAL AB RLD, RS 2012-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021976-001 PREZISTA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021976-002 PREZISTA 600MG TABLET / ORAL AB RLD 2008-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021976-003 PREZISTA 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021976-004 PREZISTA 75MG TABLET / ORAL RLD 2008-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021976-005 PREZISTA 150MG TABLET / ORAL RLD 2008-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021976-006 PREZISTA 800MG TABLET / ORAL AB RLD, RS 2012-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021976-001 PREZISTA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021976-002 PREZISTA 600MG TABLET / ORAL AB RLD 2008-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021976-003 PREZISTA 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021976-004 PREZISTA 75MG TABLET / ORAL RLD 2008-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021976-005 PREZISTA 150MG TABLET / ORAL RLD 2008-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021976-006 PREZISTA 800MG TABLET / ORAL AB RLD, RS 2012-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021976-001 PREZISTA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021976-002 PREZISTA 600MG TABLET / ORAL AB RLD 2008-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021976-003 PREZISTA 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021976-004 PREZISTA 75MG TABLET / ORAL RLD 2008-12-18 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 75 observed states.
Observed Orange Book patent history# Patent history page 1 of 28 · 1,088 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021976-001 7700645 2026-12-26 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-001 7700645*PED 2027-06-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-002 7700645 2026-12-26 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-002 7700645*PED 2027-06-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-003 7700645 2026-12-26 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-003 7700645*PED 2027-06-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-004 7700645 2026-12-26 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-004 7700645*PED 2027-06-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-005 7700645 2026-12-26 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-005 7700645*PED 2027-06-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-006 7700645 2026-12-26 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-006 7700645*PED 2027-06-26 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-001 7700645 2026-12-26 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-001 7700645*PED 2027-06-26 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-002 7700645 2026-12-26 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-002 7700645*PED 2027-06-26 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-003 7700645 2026-12-26 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-003 7700645*PED 2027-06-26 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-004 7700645 2026-12-26 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-004 7700645*PED 2027-06-26 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-005 7700645 2026-12-26 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-005 7700645*PED 2027-06-26 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-006 7700645 2026-12-26 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-006 7700645*PED 2027-06-26 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021976-001 7700645 2026-12-26 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-001 7700645*PED 2027-06-26 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-002 7700645 2026-12-26 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-002 7700645*PED 2027-06-26 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-003 7700645 2026-12-26 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-003 7700645*PED 2027-06-26 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-004 7700645 2026-12-26 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-004 7700645*PED 2027-06-26 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-005 7700645 2026-12-26 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-005 7700645*PED 2027-06-26 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-006 7700645 2026-12-26 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-006 7700645*PED 2027-06-26 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-001 7700645 2026-12-26 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-001 7700645*PED 2027-06-26 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-002 7700645 2026-12-26 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-002 7700645*PED 2027-06-26 Pediatric extension fd3edfee7708…
Additional Listing Data#
Finished product Yes
Brand name base PREZISTA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DARUNAVIR ETHANOLATE 800 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 33O78XF0BW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 670026 Internal RxNorm lookup 794610 Internal RxNorm lookup 831868 Internal RxNorm lookup 831870 Internal RxNorm lookup 850455 Internal RxNorm lookup 850457 Internal RxNorm lookup 1236628 Internal RxNorm lookup 1236632 Internal RxNorm lookup 1359269 Internal RxNorm lookup 1359271 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59676-566-30 PREZISTA 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 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 59676-566 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 59676-566-30 59676056630 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-566-30) 2012-11-09 0000-00-00 No No Current