RIVFLOZA

Product NDC: 0169-5308
Requested package NDC: 0169-5308-01
11-digit product format: 001695308
Labeler code: 0169
Product ID: 0169-5308_758d66fb-0447-4f26-905f-595b182aebdc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nedosiran
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Novo Nordisk
Application: NDA215842
Marketing category: NDA
Marketing start: 2024-02-19
Substance: NEDOSIRAN SODIUM
Active strength: 80 mg/.5mL
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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215842-001	RIVFLOZA	NEDOSIRAN SODIUM	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29
N215842-002	RIVFLOZA	NEDOSIRAN SODIUM	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29
N215842-003	RIVFLOZA	NEDOSIRAN SODIUM	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215842-001	10351854	2035-10-09		Drug substance, Drug product	2023-10-26
N215842-001	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26
N215842-001	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26
N215842-001	11053502	2035-10-29		Drug substance, Drug product	2023-10-26
N215842-001	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26
N215842-001	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26
N215842-002	10351854	2035-10-09		Drug substance, Drug product	2023-10-26
N215842-002	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26
N215842-002	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26
N215842-002	11053502	2035-10-29		Drug substance, Drug product	2023-10-26
N215842-002	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26
N215842-002	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26
N215842-003	10351854	2035-10-09		Drug substance, Drug product	2023-10-26
N215842-003	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26
N215842-003	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26
N215842-003	11053502	2035-10-29		Drug substance, Drug product	2023-10-26
N215842-003	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26
N215842-003	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215842-001	NPP	2028-03-27
N215842-001	NCE	2028-09-29
N215842-001	ODE-443	2030-09-29
N215842-001	ODE-531	2032-03-27
N215842-002	NPP	2028-03-27
N215842-002	NCE	2028-09-29
N215842-002	ODE-443	2030-09-29
N215842-002	ODE-531	2032-03-27
N215842-003	NPP	2028-03-27
N215842-003	NCE	2028-09-29
N215842-003	ODE-443	2030-09-29
N215842-003	ODE-531	2032-03-27

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 2 · 66 observed 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	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 378 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	N215842-001	10351854	2035-10-09		Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-001	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-001	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-001	11053502	2035-10-29		Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-001	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-001	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-002	10351854	2035-10-09		Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-002	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-002	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-002	11053502	2035-10-29		Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-002	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-002	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-003	10351854	2035-10-09		Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-003	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-003	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-003	11053502	2035-10-29		Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-003	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-003	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215842-001	10351854	2035-10-09		Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-001	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-001	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-001	11053502	2035-10-29		Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-001	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-001	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	10351854	2035-10-09		Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	11053502	2035-10-29		Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	10351854	2035-10-09		Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	11053502	2035-10-29		Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215842-001	10351854	2035-10-09		Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-001	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-001	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-001	11053502	2035-10-29		Drug substance, Drug product	2023-10-26	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 153 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N215842-001	NPP	2028-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-001	NCE	2028-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-001	ODE-443	2030-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-001	ODE-531	2032-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-002	NPP	2028-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-002	NCE	2028-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-002	ODE-443	2030-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-002	ODE-531	2032-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-003	NPP	2028-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-003	NCE	2028-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-003	ODE-443	2030-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215842-003	ODE-531	2032-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215842-001	NPP	2028-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-001	NCE	2028-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-001	ODE-443	2030-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-001	ODE-531	2032-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	NPP	2028-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	NCE	2028-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	ODE-443	2030-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	ODE-531	2032-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	NPP	2028-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	NCE	2028-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	ODE-443	2030-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	ODE-531	2032-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215842-001	NPP	2028-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-001	NCE	2028-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-001	ODE-443	2030-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-002	NPP	2028-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-002	NCE	2028-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-002	ODE-443	2030-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-003	NPP	2028-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-003	NCE	2028-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-003	ODE-443	2030-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-001	NPP	2028-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-001	NCE	2028-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-001	ODE-443	2030-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-002	NPP	2028-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-002	NCE	2028-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-002	ODE-443	2030-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-003	NPP	2028-03-27	`31067a03dcf5…`

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: RIVFLOZA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NEDOSIRAN SODIUM	80 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EGR9KYM536	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2675303	Internal RxNorm lookup
2675309	Internal RxNorm lookup
2675312	Internal RxNorm lookup
2675315	Internal RxNorm lookup
2675317	Internal RxNorm lookup
2675318	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
ace9d4bc-4d20-4beb-9e9d-888690424833	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5a285934-1981-4741-8f3a-09f5134b4711	Product name	1	20250625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0169-5308-01	RIVFLOZA	0.5 mL in 1 VIAL	INJECTION, SOLUTION	0.5		4
0169-5308-01	RIVFLOZA	1 in 1 CARTON	INJECTION, SOLUTION	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0169-5308-01	ML - Milliliter	0169-5308	245f34b1-fb73-4fd9-86e6-08d7f2b4f8ad	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0169-5308	RIVFLOZA (NEDOSIRAN) INJECTION, SOLUTION [NOVO NORDISK]	4	Current NDC, 2 package rows	20250410_ace9d4bc-4d20-4beb-9e9d-888690424833.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
RIVFLOZA	NEDOSIRAN	Novo Nordisk	ace9d4bc-4d20-4beb-9e9d-888690424833	2025-03-03	Adverse reactions	Exact identifier application applno (NDA): 215842 application number: NDA215842 ndc (package): 0169-5308-01 ndc (product): 0169-5308 ndc11 (package): 00169530801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2675312	nedosiran 128 MG in 0.8 ML Prefilled Syringe	PSN	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675317	nedosiran 160 MG in 1 ML Prefilled Syringe	PSN	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675303	nedosiran 80 MG in 0.5 ML Injection	PSN	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675315	rivfloza 128 MG in 0.8 ML Prefilled Syringe	PSN	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675318	rivfloza 160 MG in 1 ML Prefilled Syringe	PSN	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675309	rivfloza 80 MG in 0.5 ML Injection	PSN	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675309	0.5 ML nedosiran 160 MG/ML Injection [Rivfloza]	SBD	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675315	0.8 ML nedosiran 160 MG/ML Prefilled Syringe [Rivfloza]	SBD	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675318	1 ML nedosiran 160 MG/ML Prefilled Syringe [Rivfloza]	SBD	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675303	0.5 ML nedosiran 160 MG/ML Injection	SCD	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675312	0.8 ML nedosiran 160 MG/ML Prefilled Syringe	SCD	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675317	1 ML nedosiran 160 MG/ML Prefilled Syringe	SCD	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675309	0.5 ML Rivfloza 160 MG/ML Injection	SY	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675315	0.8 ML Rivfloza 160 MG/ML Prefilled Syringe	SY	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675318	1 ML Rivfloza 160 MG/ML Prefilled Syringe	SY	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675312	nedosiran 128 MG (as nedosiran sodium 136 MG) per 0.8 ML Prefilled Syringe	SY	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675317	nedosiran 160 MG (as nedosiran sodium 170 MG) per 1 ML Prefilled Syringe	SY	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675303	nedosiran 80 MG (as nedosiran sodium 85 MG) per 0.5 ML Injection	SY	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675315	Rivfloza 128 MG per 0.8 ML Prefilled Syringe	SY	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675318	Rivfloza 160 MG per 1 ML Prefilled Syringe	SY	ace9d4bc-4d20-4beb-9e9d-888690424833	4
2675309	Rivfloza 80 MG per 0.5 ML Injection	SY	ace9d4bc-4d20-4beb-9e9d-888690424833	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0169-5308-01	00169530801	1 VIAL in 1 CARTON (0169-5308-01) / .5 mL in 1 VIAL	1 vial	2024-02-19	No	No	Current