Paxlovid

Product NDC: 0069-5045
11-digit product format: 000695045
Labeler code: 0069
Product ID: 0069-5045_d20f905e-5c85-4ad4-ab46-871ce4f6669e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nirmatrelvir and ritonavir
Dosage form: KIT
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: NDA217188
Marketing category: NDA
Marketing start: 2025-07-09
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 20 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
2025-04-01 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	0069-5045-30	`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	0069-5045-30	`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	0069-5045-30	`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	0069-5045-30	`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	0069-5045-30	`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	0069-5045-30	`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	0069-5045-30	`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	0069-5045-30	`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	0069-5045-30	`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	0069-5045-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217188-001	PAXLOVID (COPACKAGED)	NIRMATRELVIR; RITONAVIR	150MG;100MG	TABLET / ORAL		RLD, RS	2023-05-25

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23
N217188-001	11541034	2041-10-31	U-3629		2023-06-23

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217188-001	D-195	2028-01-31
N217188-001	NCE	2028-05-25

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`a72a2bbeb626…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N217188-001	D-195	2028-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217188-001	NCE	2028-05-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217188-001	D-195	2028-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217188-001	NCE	2028-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217188-001	D-195	2028-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217188-001	NCE	2028-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217188-001	D-195	2028-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217188-001	NCE	2028-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217188-001	D-195	2028-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217188-001	NCE	2028-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217188-001	D-195	2028-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217188-001	NCE	2028-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217188-001	NCE	2028-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217188-001	NCE	2028-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217188-001	NCE	2028-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217188-001	NCE	2028-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217188-001	NCE	2028-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217188-001	NCE	2028-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217188-001	NCE	2028-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217188-001	NCE	2028-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217188-002	NCE	2028-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217188-001	NCE	2028-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217188-002	NCE	2028-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217188-001	NCE	2028-05-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217188-002	NCE	2028-05-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217188-001	NCE	2028-05-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217188-002	NCE	2028-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217188-001	NCE	2028-05-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217188-002	NCE	2028-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217188-001	NCE	2028-05-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N217188-002	NCE	2028-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217188-001	NCE	2028-05-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217188-002	NCE	2028-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217188-001	NCE	2028-05-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217188-002	NCE	2028-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217188-001	NCE	2028-05-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217188-002	NCE	2028-05-25	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217188-001	D-195	2028-01-31	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217188-001	NCE	2028-05-25	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Paxlovid
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
900575	Internal RxNorm lookup
2587897	Internal RxNorm lookup
2587898	Internal RxNorm lookup
2587899	Internal RxNorm lookup
2599542	Internal RxNorm lookup
2599543	Internal RxNorm lookup
2704986	Internal RxNorm lookup
2704987	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
8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1d2364f5-8b1e-7c9a-4518-7b359d95fa50	Product name	2	20250116
00d976a9-a12a-db3d-ac4e-27498af714cf	Product name	5	20250115
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
7a5f5ac7-15c0-4d8b-bea4-b3b28cb83a8d	Product name	1	20231023
c8f34825-48cd-e7db-4048-c3be840a9308	Product name	5	20230123
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d1ee4fdb-1116-417b-8889-dc05571445b3	Product name	1	20160825
f8d26468-b1dc-49d8-a188-8b5d531405ef	Product name	1	20150731
0b1bb9d1-e628-4e7c-aada-fd6532257932	Product name	1	20150416
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
96979b26-bb9a-43d8-e3a6-d69b9e9f75e5	Product name	1	20140508
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
0069-1345-11	Paxlovid	1 in 1 BLISTER PACK	TABLET, FILM COATED	10	100 mg	12
0069-2085-02	Paxlovid	2 in 1 BLISTER PACK	TABLET, FILM COATED	20	150 mg	12
0069-5045-06	Paxlovid	1 in 1 BLISTER PACK	KIT	1		12
0069-5045-30	Paxlovid	10 in 1 CARTON	KIT	10		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-5045-06	EA - Each	0069-5045	c8588c2f-cac7-4ec0-a931-4fc5263050e2	1	2025-08-11
0069-5045-30	EA - Each	0069-5045	24ce323d-6c75-4615-bc15-d80e34d205c2	1	2025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0069-5045	PAXLOVID (NIRMATRELVIR AND RITONAVIR) KIT [PFIZER LABORATORIES DIV PFIZER INC]	8	Current NDC, 4 package rows	20250417_8a99d6d6-fd9e-45bb-b1bf-48c7f761232a.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
Paxlovid	NIRMATRELVIR AND RITONAVIR	Pfizer Laboratories Div Pfizer Inc	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 217188 application number: NDA217188 ndc (product): 0069-5045

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2599543	{10 (nirmatrelvir 150 MG Oral Tablet) / 10 (ritonavir 100 MG Oral Tablet) } Pack [Paxlovid 150 MG /100 MG Dose Pack]	BPCK	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2587899	{20 (nirmatrelvir 150 MG Oral Tablet) / 10 (ritonavir 100 MG Oral Tablet) } Pack [Paxlovid 5-Day]	BPCK	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2704987	{6 (nirmatrelvir 150 MG Oral Tablet) / 5 (ritonavir 100 MG Oral Tablet) } Pack [Paxlovid 300 MG /100 MG ; 150 MG / 100 MG Dose Pack]	BPCK	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2599542	{10 (nirmatrelvir 150 MG Oral Tablet) / 10 (ritonavir 100 MG Oral Tablet) } Pack	GPCK	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2587898	{20 (nirmatrelvir 150 MG Oral Tablet) / 10 (ritonavir 100 MG Oral Tablet) } Pack	GPCK	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2704986	{6 (nirmatrelvir 150 MG Oral Tablet) / 5 (ritonavir 100 MG Oral Tablet) } Pack	GPCK	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2704986	nirmatrelvir / ritonavir 300 MG /100 MG ; 150 MG / 100 MG Dose Pack	PSN	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2599542	nirmatrelvir 150 MG ; ritonavir 100 MG Daily Dose Pack, Renal	PSN	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2587897	nirmatrelvir 150 MG Oral Tablet	PSN	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2587898	nirmatrelvir 300 MG ; ritonavir 100 MG Daily Dose Pack	PSN	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2599543	PAXLOVID 150 MG ; 100 MG Dose Pack, Renal	PSN	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2704987	PAXLOVID 300 MG ; 100 MG (Day 1), 150 MG ; 100 MG (Days 2-5) Dose Pack	PSN	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2587899	PAXLOVID 300 MG ; 100 MG Dose Pack	PSN	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
900575	ritonavir 100 MG Oral Tablet	PSN	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2587897	nirmatrelvir 150 MG Oral Tablet	SCD	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
900575	ritonavir 100 MG Oral Tablet	SCD	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2599542	nirmatrelvir 150 MG Oral Tablet (10) / ritonavir 100 MG Oral Tablet (10) 150 MG /100 MG Dose Pack	SY	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2587898	nirmatrelvir 150 MG Oral Tablet (20) / ritonavir 100 MG Oral Tablet (10) 5-Day Pack	SY	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2704986	nirmatrelvir 150 MG Oral Tablet (6) / ritonavir 100 MG Oral Tablet (5) 300 MG /100 MG ; 150 MG / 100 MG Dose Pack	SY	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2599543	Paxlovid 150 MG / 100 MG Dose Pack	SY	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2704987	Paxlovid 300 MG / 100 MG ; 150 MG / 100 MG Dose Pack	SY	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12
2587899	Paxlovid 300 MG / 100 MG Dose Pack	SY	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0069-1345-11	00069134511	1 in 1 BLISTER PACK					Historical
0069-2085-02	00069208502	2 in 1 BLISTER PACK					Historical
0069-5045-06	00069504506	1 in 1 BLISTER PACK					Historical
0069-5045-30	00069504530	10 BLISTER PACK in 1 CARTON (0069-5045-30) / 1 KIT in 1 BLISTER PACK (0069-5045-06) * 2 TABLET, FILM COATED in 1 BLISTER PACK (0069-2085-02) * 1 TABLET, FILM COATED in 1 BLISTER PACK (0069-1345-11)	10 blister pack	2025-07-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Paxlovid	Pfizer Laboratories Div Pfizer Inc \| Pfizer Inc \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH \| Pfizer Italia S.r.l. \| Pharmacia & Upjohn Company LLC	2026-02-19	HUMAN PRESCRIPTION DRUG LABEL	12