PREZISTA

Product NDC: 53808-0672
11-digit product format: 538080672
Labeler code: 53808
Product ID: 53808-0672_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: 400 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: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-0672		I	Inactivated by FDA		2026-08-10
excluded package	package	53808-0672	53808-0672-1	I	Inactivated by FDA		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-0672-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-0672-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-0672-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0672-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0672-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0672-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0672-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0672-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0672-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0672-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0672-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0672-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0672-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0672-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0672-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0672-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0672-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0672-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0672-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0672-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0672-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53808-0672-1	`110d247fa046…`	`a55b01930146…`

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…`

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0672-1	2021-01-29	C162847	48780-1	956f9ecf-c58e-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use PREZISTA safely and effectively. See Full Prescribing Information for PREZISTA. PREZISTA (darunavir) Tablet, Film Coated for Oral use Initial U.S. Approval – 2006
53808-0672-1	2019-10-21	C162847	48780-1	956f9ecf-c58e-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use PREZISTA safely and effectively. See Full Prescribing Information for PREZISTA. PREZISTA (darunavir) Tablet, Film Coated for Oral use Initial U.S. Approval – 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0672-1	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
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
53808-0672	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

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
33O78XF0BW	DARUNAVIR ETHANOLATE	635728-49-3	DARUNAVIR ETHANOLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0672-1	53808067201	30 in 1 BLISTER PACK	Historical