AMVUTTRA

Product NDC: 71336-1003
11-digit product format: 713361003
Labeler code: 71336
Product ID: 71336-1003_1791a81a-d261-4b66-b699-273afe02c380
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VUTRISIRAN
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Alnylam Pharmaceuticals, Inc.
Application: NDA215515
Marketing category: NDA
Marketing start: 2022-06-13
Substance: VUTRISIRAN SODIUM
Active strength: 25 mg/.5mL
Pharmacologic classes: Decreased RNA Integrity [PE], Increased Protein Breakdown [PE], RNA, Small Interfering [CS], Small Interfering RNA [EPC], Transthyretin-directed RNA Interaction [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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215515-001	AMVUTTRA	VUTRISIRAN SODIUM	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2022-06-13

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215515-001	10131907	2028-08-24	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	10806791	2028-12-04		Drug substance	2022-07-13
N215515-001	8828956	2028-12-04	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	9370581	2028-12-04	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	8106022	2029-12-12	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	10570391	2032-11-16	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	9399775	2032-11-16	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	10612024	2035-08-14	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	11401517	2035-08-14	U-3396	Drug substance, Drug product	2022-08-31
N215515-001	10208307	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	10683501	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	11286486	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	12049628	2036-07-28	U-3396	Drug substance, Drug product	2024-08-28

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215515-001	NCE	2027-06-13
N215515-001	I-964	2028-03-20
N215515-001	ODE-212	2029-06-13
N215515-001	ODE-527	2032-03-20

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
2026-02-19 14:30 UTC	2026-02	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215515-001	AMVUTTRA	25MG/0.5ML (25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215515-001	AMVUTTRA	25MG/0.5ML (25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215515-001	AMVUTTRA	25MG/0.5ML (25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215515-001	AMVUTTRA	25MG/0.5ML (25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215515-001	AMVUTTRA	25MG/0.5ML (25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 335 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215515-001	10131907	2028-08-24	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	10806791	2028-12-04		Drug substance	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	8828956	2028-12-04	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	9370581	2028-12-04	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	8106022	2029-12-12	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	10570391	2032-11-16	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	9399775	2032-11-16	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	10612024	2035-08-14	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	11401517	2035-08-14	U-3396	Drug substance, Drug product	2022-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	10208307	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	10683501	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	11286486	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	12049628	2036-07-28	U-3396	Drug substance, Drug product	2024-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	10131907	2028-08-24	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	10806791	2028-12-04		Drug substance	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	8828956	2028-12-04	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	9370581	2028-12-04	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	8106022	2029-12-12	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	10570391	2032-11-16	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	9399775	2032-11-16	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	10612024	2035-08-14	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	11401517	2035-08-14	U-3396	Drug substance, Drug product	2022-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	10208307	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	10683501	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	11286486	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	12049628	2036-07-28	U-3396	Drug substance, Drug product	2024-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215515-001	10131907	2028-08-24	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	10806791	2028-12-04		Drug substance	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	8828956	2028-12-04	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	9370581	2028-12-04	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	8106022	2029-12-12	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	10570391	2032-11-16	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	9399775	2032-11-16	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	10612024	2035-08-14	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	11401517	2035-08-14	U-3396	Drug substance, Drug product	2022-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	10208307	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	10683501	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	11286486	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	12049628	2036-07-28	U-3396	Drug substance, Drug product	2024-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215515-001	10131907	2028-08-24	U-3396	Drug substance, Drug product	2022-07-13	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215515-001	NCE	2027-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	I-964	2028-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	ODE-212	2029-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	NCE	2027-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	I-964	2028-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	ODE-212	2029-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215515-001	NCE	2027-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	I-964	2028-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	ODE-212	2029-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215515-001	NCE	2027-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215515-001	ODE-212	2029-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215515-001	NCE	2027-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215515-001	ODE-212	2029-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215515-001	NCE	2027-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215515-001	ODE-212	2029-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215515-001	NCE	2027-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215515-001	ODE-212	2029-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215515-001	NCE	2027-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215515-001	ODE-212	2029-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215515-001	NCE	2027-06-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215515-001	ODE-212	2029-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215515-001	NCE	2027-06-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215515-001	ODE-212	2029-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215515-001	NCE	2027-06-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215515-001	ODE-212	2029-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215515-001	NCE	2027-06-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215515-001	ODE-212	2029-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215515-001	NCE	2027-06-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215515-001	ODE-212	2029-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215515-001	NCE	2027-06-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215515-001	ODE-212	2029-06-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215515-001	NCE	2027-06-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215515-001	ODE-212	2029-06-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215515-001	NCE	2027-06-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N215515-001	ODE-212	2029-06-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215515-001	NCE	2027-06-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N215515-001	ODE-212	2029-06-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215515-001	NCE	2027-06-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215515-001	ODE-212	2029-06-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215515-001	NCE	2027-06-13	`9b2671bbb829…`

Additional Listing Data#

Finished product: Yes
Brand name base: AMVUTTRA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VUTRISIRAN SODIUM	25 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
28O0WP6Z1P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2604788	Internal RxNorm lookup
2604794	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
8db0facb-81b6-4006-9239-27dc6409c5d3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
13d3bd13-5634-4682-9348-7ee2710acc8b	Product name	1	20230310

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71336-1003-1	AMVUTTRA	1 in 1 CARTON	INJECTION	1		8
71336-1003-1	AMVUTTRA	0.5 mL in 1 SYRINGE, GLASS	INJECTION	0.5		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71336-1003-1	ML - Milliliter	71336-1003	e88da143-aa5e-412f-a03f-cc540e1bc7b3	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71336-1003	AMVUTTRA (VUTRISIRAN) INJECTION [ALNYLAM PHARMACEUTICALS, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20250331_8db0facb-81b6-4006-9239-27dc6409c5d3.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
AMVUTTRA	VUTRISIRAN	Alnylam Pharmaceuticals, Inc.	8db0facb-81b6-4006-9239-27dc6409c5d3	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215515 application number: NDA215515 ndc (product): 71336-1003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2604794	amvuttra 25 MG in 0.5 ML Prefilled Syringe	PSN	8db0facb-81b6-4006-9239-27dc6409c5d3	8
2604788	vutrisiran 25 MG in 0.5 ML Prefilled Syringe	PSN	8db0facb-81b6-4006-9239-27dc6409c5d3	8
2604794	0.5 ML vutrisiran 50 MG/ML Prefilled Syringe [Amvuttra]	SBD	8db0facb-81b6-4006-9239-27dc6409c5d3	8
2604788	0.5 ML vutrisiran 50 MG/ML Prefilled Syringe	SCD	8db0facb-81b6-4006-9239-27dc6409c5d3	8
2604794	0.5 ML Amvuttra 50 MG/ML Prefilled Syringe	SY	8db0facb-81b6-4006-9239-27dc6409c5d3	8
2604794	Amvuttra 25 MG per 0.5 ML Prefilled Syringe	SY	8db0facb-81b6-4006-9239-27dc6409c5d3	8
2604788	vutrisiran 25 MG (as vutrisiran sodium 26.5 MG) per 0.5 ML Prefilled Syringe	SY	8db0facb-81b6-4006-9239-27dc6409c5d3	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71336-1003-1	71336100301	1 SYRINGE, GLASS in 1 CARTON (71336-1003-1) / .5 mL in 1 SYRINGE, GLASS	2022-06-13	0000-00-00	No	No	Current