PREZISTA

Product NDC: 59676-562
11-digit product format: 596760562
Labeler code: 59676
Product ID: 59676-562_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: 2008-03-08
Substance: DARUNAVIR ETHANOLATE
Active strength: 600 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N021976-001	PREZISTA	DARUNAVIR	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-23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N021976-003	PREZISTA	DARUNAVIR	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2008-10-21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.

Application-product, TE code table
Application-product	TE code
N021976-002	AB
N021976-004	AB
N021976-005	AB
N021976-006	AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021976-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021976-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021976-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021976-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021976-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021976-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021976-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021976-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021976-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021976-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021976-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021976-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021976-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021976-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021976-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021976-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021976-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021976-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021976-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021976-006	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021976-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021976-006	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021976-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021976-006	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021976-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021976-006	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021976-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021976-006	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021976-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021976-006	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021976-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021976-006	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021976-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021976-006	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021976-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021976-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021976-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021976-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021976-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021976-002	AB	1	`782e0a99824c…`

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	Coverage / status	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	600 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
814301f9-c990-46a5-b481-2879a521a16f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
81157882-d7f5-4b49-9a52-b2a0c7e54020	Product name	2	20260107
12fd8c59-0b3a-2882-9cdb-92782ec03e2f	Product name	6	20251113
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7	Product name	1	20180911
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59676-562-01	PREZISTA	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60		58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59676-562-01	EA - Each	59676-562	537c9b7d-e5f9-42c1-aba9-575fe59dd922	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
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
darunavir ethanolate	ACTIVE INGREDIENT	33O78XF0BW	PREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
darunavir	ACTIVE MOIETY	YO603Y8113	PREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	PREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
crospovidone	INACTIVE INGREDIENT	68401960MK	PREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	PREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
polyethylene glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	PREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	PREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
talc	INACTIVE INGREDIENT	7SEV7J4R1U	PREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59676-562	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PREZISTA	DARUNAVIR	Janssen Products LP	814301f9-c990-46a5-b481-2879a521a16f	2025-08-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021976 application number: NDA021976 ndc (product): 59676-562

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
33O78XF0BW	DARUNAVIR ETHANOLATE	635728-49-3	DARUNAVIR ETHANOLATE
YO603Y8113	DARUNAVIR	206361-99-1	darunavir

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1236628	darunavir 100 MG in 1 mL Oral Suspension	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
850455	darunavir 150 MG Oral Tablet	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
670026	darunavir 600 MG Oral Tablet	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
831868	darunavir 75 MG Oral Tablet	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
1359269	darunavir 800 MG Oral Tablet	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
1236632	PREZISTA 100 MG in 1 mL Oral Suspension	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
850457	PREZISTA 150 MG Oral Tablet	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
794610	PREZISTA 600 MG Oral Tablet	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
831870	PREZISTA 75 MG Oral Tablet	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
1359271	Prezista 800 MG Oral Tablet	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
1236632	darunavir 100 MG/ML Oral Suspension [Prezista]	SBD	814301f9-c990-46a5-b481-2879a521a16f	58
850457	darunavir 150 MG Oral Tablet [Prezista]	SBD	814301f9-c990-46a5-b481-2879a521a16f	58
794610	darunavir 600 MG Oral Tablet [Prezista]	SBD	814301f9-c990-46a5-b481-2879a521a16f	58
831870	darunavir 75 MG Oral Tablet [Prezista]	SBD	814301f9-c990-46a5-b481-2879a521a16f	58
1359271	darunavir 800 MG Oral Tablet [Prezista]	SBD	814301f9-c990-46a5-b481-2879a521a16f	58
1236628	darunavir 100 MG/ML Oral Suspension	SCD	814301f9-c990-46a5-b481-2879a521a16f	58
850455	darunavir 150 MG Oral Tablet	SCD	814301f9-c990-46a5-b481-2879a521a16f	58
670026	darunavir 600 MG Oral Tablet	SCD	814301f9-c990-46a5-b481-2879a521a16f	58
831868	darunavir 75 MG Oral Tablet	SCD	814301f9-c990-46a5-b481-2879a521a16f	58
1359269	darunavir 800 MG Oral Tablet	SCD	814301f9-c990-46a5-b481-2879a521a16f	58
670026	darunavir (as darunavir ethanolate) 600 MG Oral Tablet	SY	814301f9-c990-46a5-b481-2879a521a16f	58
1359269	darunavir (as darunavir ethanolate) 800 MG Oral Tablet	SY	814301f9-c990-46a5-b481-2879a521a16f	58
670026	darunavir (as darunavir hydrate) 600 MG Oral Tablet	SY	814301f9-c990-46a5-b481-2879a521a16f	58
1236628	darunavir 100 MG per 1 ML Oral Suspension	SY	814301f9-c990-46a5-b481-2879a521a16f	58
1236632	Prezista 100 MG per 1 ML Oral Suspension	SY	814301f9-c990-46a5-b481-2879a521a16f	58
1236632	Prezista 100 MG/ML Oral Suspension	SY	814301f9-c990-46a5-b481-2879a521a16f	58
850457	Prezista 150 MG Oral Tablet	SY	814301f9-c990-46a5-b481-2879a521a16f	58
794610	Prezista 600 MG (as darunavir ethanolate ) Oral Tablet	SY	814301f9-c990-46a5-b481-2879a521a16f	58
794610	Prezista 600 MG Oral Tablet	SY	814301f9-c990-46a5-b481-2879a521a16f	58
831870	Prezista 75 MG Oral Tablet	SY	814301f9-c990-46a5-b481-2879a521a16f	58
1359271	Prezista 800 MG Oral Tablet	SY	814301f9-c990-46a5-b481-2879a521a16f	58
824338	darunavir 400 MG Oral Tablet	PSN	4cde01bb-230b-42d8-a9e1-4c7da1a01b76	3
670026	darunavir 600 MG Oral Tablet	PSN	4cde01bb-230b-42d8-a9e1-4c7da1a01b76	3
824876	PREZISTA 400 MG Oral Tablet	PSN	4cde01bb-230b-42d8-a9e1-4c7da1a01b76	3
794610	PREZISTA 600 MG Oral Tablet	PSN	4cde01bb-230b-42d8-a9e1-4c7da1a01b76	3
824876	darunavir 400 MG Oral Tablet [Prezista]	SBD	4cde01bb-230b-42d8-a9e1-4c7da1a01b76	3
794610	darunavir 600 MG Oral Tablet [Prezista]	SBD	4cde01bb-230b-42d8-a9e1-4c7da1a01b76	3
824338	darunavir 400 MG Oral Tablet	SCD	4cde01bb-230b-42d8-a9e1-4c7da1a01b76	3
670026	darunavir 600 MG Oral Tablet	SCD	4cde01bb-230b-42d8-a9e1-4c7da1a01b76	3
824338	darunavir (as darunavir ethanolate) 400 MG Oral Tablet	SY	4cde01bb-230b-42d8-a9e1-4c7da1a01b76	3
670026	darunavir (as darunavir ethanolate) 600 MG Oral Tablet	SY	4cde01bb-230b-42d8-a9e1-4c7da1a01b76	3
670026	darunavir (as darunavir hydrate) 600 MG Oral Tablet	SY	4cde01bb-230b-42d8-a9e1-4c7da1a01b76	3
824876	Prezista 400 MG Oral Tablet	SY	4cde01bb-230b-42d8-a9e1-4c7da1a01b76	3
794610	Prezista 600 MG (as darunavir ethanolate ) Oral Tablet	SY	4cde01bb-230b-42d8-a9e1-4c7da1a01b76	3
794610	Prezista 600 MG Oral Tablet	SY	4cde01bb-230b-42d8-a9e1-4c7da1a01b76	3
824338	darunavir 400 MG Oral Tablet	PSN	13671be1-b4b4-44c9-a27d-0727f937bb3c	2
670026	darunavir 600 MG Oral Tablet	PSN	13671be1-b4b4-44c9-a27d-0727f937bb3c	2
824876	PREZISTA 400 MG Oral Tablet	PSN	13671be1-b4b4-44c9-a27d-0727f937bb3c	2
794610	PREZISTA 600 MG Oral Tablet	PSN	13671be1-b4b4-44c9-a27d-0727f937bb3c	2
824876	darunavir 400 MG Oral Tablet [Prezista]	SBD	13671be1-b4b4-44c9-a27d-0727f937bb3c	2
794610	darunavir 600 MG Oral Tablet [Prezista]	SBD	13671be1-b4b4-44c9-a27d-0727f937bb3c	2
824338	darunavir 400 MG Oral Tablet	SCD	13671be1-b4b4-44c9-a27d-0727f937bb3c	2
670026	darunavir 600 MG Oral Tablet	SCD	13671be1-b4b4-44c9-a27d-0727f937bb3c	2
824338	darunavir (as darunavir ethanolate) 400 MG Oral Tablet	SY	13671be1-b4b4-44c9-a27d-0727f937bb3c	2
670026	darunavir (as darunavir ethanolate) 600 MG Oral Tablet	SY	13671be1-b4b4-44c9-a27d-0727f937bb3c	2
670026	darunavir (as darunavir hydrate) 600 MG Oral Tablet	SY	13671be1-b4b4-44c9-a27d-0727f937bb3c	2
824876	Prezista 400 MG Oral Tablet	SY	13671be1-b4b4-44c9-a27d-0727f937bb3c	2
794610	Prezista 600 MG (as darunavir ethanolate ) Oral Tablet	SY	13671be1-b4b4-44c9-a27d-0727f937bb3c	2
794610	Prezista 600 MG Oral Tablet	SY	13671be1-b4b4-44c9-a27d-0727f937bb3c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59676-562-01	59676056201	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-562-01)	2008-03-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PREZISTA	Janssen Products LP \| Janssen Pharmaceuticals, Inc \| Janssen Pharmaceutica NV \| Cilag AG \| Porton Pharma Solutions Ltd \| Janssen Cilag SpA \| JANSSEN ORTHO LLC \| Janssen Pharmaceutical Sciences Unlimited Company \| Thermo Fisher Scientific Cork Limited	2025-08-29	HUMAN PRESCRIPTION DRUG LABEL	58
PREZISTA	A-S Medication Solutions	2019-03-22	HUMAN PRESCRIPTION DRUG LABEL	14
PREZISTA	REMEDYREPACK INC.	2018-03-23	HUMAN PRESCRIPTION DRUG LABEL	2
PREZISTA	Physicians Total Care, Inc.	2012-10-22	HUMAN PRESCRIPTION DRUG LABEL	2
PREZISTA	State of Florida DOH Central Pharmacy	2010-08-23	HUMAN PRESCRIPTION DRUG LABEL	3