GIVLAARI

Product NDC: 71336-1001
11-digit product format: 713361001
Labeler code: 71336
Product ID: 71336-1001_942492a0-de6e-4c31-8b9c-d259f808d821
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: givosiran sodium
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Alnylam Pharmaceuticals, Inc.
Application: NDA212194
Marketing category: NDA
Marketing start: 2019-12-12
Substance: GIVOSIRAN SODIUM
Active strength: 189 mg/mL
Pharmacologic classes: Aminolevulinate Synthase 1-directed RNA Interaction [EPC], Decreased RNA Integrity [PE], RNA, Small Interfering [CS], Small Interfering RNA [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
N212194-001	GIVLAARI	GIVOSIRAN SODIUM	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2019-11-20

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212194-001	10131907	2028-08-24	U-2672	Drug substance, Drug product	2019-12-12
N212194-001	8828956	2028-12-04	U-2672	Drug substance, Drug product	2019-12-12
N212194-001	8106022	2029-12-12	U-2672	Drug substance, Drug product	2019-12-12
N212194-001	10125364	2033-03-15	U-2672	Drug substance, Drug product	2019-12-12
N212194-001	9631193	2033-03-15	U-2672		2019-12-12
N212194-001	9133461	2033-11-30	U-2672	Drug substance, Drug product	2019-12-12
N212194-001	10119143	2034-10-03	U-2672	Drug substance, Drug product	2019-12-12
N212194-001	11028392	2034-10-03	U-2672	Drug substance, Drug product	2022-02-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212194-001	ODE-273	2026-11-20

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	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 439 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	N212194-001	10131907	2028-08-24	U-2672	Drug substance, Drug product	2019-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212194-001	8828956	2028-12-04	U-2672	Drug substance, Drug product	2019-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212194-001	8106022	2029-12-12	U-2672	Drug substance, Drug product	2019-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212194-001	10125364	2033-03-15	U-2672	Drug substance, Drug product	2019-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212194-001	9631193	2033-03-15	U-2672		2019-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212194-001	9133461	2033-11-30	U-2672	Drug substance, Drug product	2019-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212194-001	10119143	2034-10-03	U-2672	Drug substance, Drug product	2019-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212194-001	11028392	2034-10-03	U-2672	Drug substance, Drug product	2022-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	9150605	2025-08-28		Drug substance, Drug product	2019-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	10131907	2028-08-24	U-2672	Drug substance, Drug product	2019-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	8828956	2028-12-04	U-2672	Drug substance, Drug product	2019-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	8106022	2029-12-12	U-2672	Drug substance, Drug product	2019-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	10125364	2033-03-15	U-2672	Drug substance, Drug product	2019-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	9631193	2033-03-15	U-2672		2019-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	9133461	2033-11-30	U-2672	Drug substance, Drug product	2019-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	10119143	2034-10-03	U-2672	Drug substance, Drug product	2019-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	11028392	2034-10-03	U-2672	Drug substance, Drug product	2022-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212194-001	9150605	2025-08-28		Drug substance, Drug product	2019-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212194-001	10131907	2028-08-24	U-2672	Drug substance, Drug product	2019-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212194-001	8828956	2028-12-04	U-2672	Drug substance, Drug product	2019-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212194-001	8106022	2029-12-12	U-2672	Drug substance, Drug product	2019-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212194-001	10125364	2033-03-15	U-2672	Drug substance, Drug product	2019-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212194-001	9631193	2033-03-15	U-2672		2019-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212194-001	9133461	2033-11-30	U-2672	Drug substance, Drug product	2019-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212194-001	10119143	2034-10-03	U-2672	Drug substance, Drug product	2019-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212194-001	11028392	2034-10-03	U-2672	Drug substance, Drug product	2022-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	9150605	2025-08-28		Drug substance, Drug product	2019-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	10131907	2028-08-24	U-2672	Drug substance, Drug product	2019-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	8828956	2028-12-04	U-2672	Drug substance, Drug product	2019-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	8106022	2029-12-12	U-2672	Drug substance, Drug product	2019-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	10125364	2033-03-15	U-2672	Drug substance, Drug product	2019-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	9631193	2033-03-15	U-2672		2019-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	9133461	2033-11-30	U-2672	Drug substance, Drug product	2019-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	10119143	2034-10-03	U-2672	Drug substance, Drug product	2019-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	11028392	2034-10-03	U-2672	Drug substance, Drug product	2022-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212194-001	9150605	2025-08-28		Drug substance, Drug product	2019-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212194-001	10131907	2028-08-24	U-2672	Drug substance, Drug product	2019-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212194-001	8828956	2028-12-04	U-2672	Drug substance, Drug product	2019-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212194-001	8106022	2029-12-12	U-2672	Drug substance, Drug product	2019-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212194-001	10125364	2033-03-15	U-2672	Drug substance, Drug product	2019-12-12	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 69 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	N212194-001	ODE-273	2026-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	ODE-273	2026-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212194-001	ODE-273	2026-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	ODE-273	2026-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212194-001	ODE-273	2026-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212194-001	NCE	2024-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212194-001	ODE-273	2026-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212194-001	NCE	2024-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212194-001	ODE-273	2026-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212194-001	NCE	2024-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212194-001	ODE-273	2026-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212194-001	NCE	2024-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212194-001	ODE-273	2026-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212194-001	NCE	2024-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212194-001	ODE-273	2026-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212194-001	NCE	2024-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212194-001	ODE-273	2026-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212194-001	NCE	2024-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212194-001	ODE-273	2026-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212194-001	NCE	2024-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212194-001	ODE-273	2026-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212194-001	NCE	2024-11-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212194-001	ODE-273	2026-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212194-001	NCE	2024-11-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212194-001	ODE-273	2026-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212194-001	NCE	2024-11-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212194-001	ODE-273	2026-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212194-001	NCE	2024-11-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212194-001	ODE-273	2026-11-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212194-001	NCE	2024-11-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212194-001	ODE-273	2026-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212194-001	NCE	2024-11-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212194-001	ODE-273	2026-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212194-001	NCE	2024-11-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212194-001	ODE-273	2026-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212194-001	NCE	2024-11-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N212194-001	ODE-273	2026-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212194-001	NCE	2024-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N212194-001	ODE-273	2026-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212194-001	NCE	2024-11-20	`c0c555d07b60…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GIVOSIRAN SODIUM	189 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5XE21E41RT	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2265716	Internal RxNorm lookup
2265721	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
167e663c-11e1-497b-a3fc-951d65d58eaa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
76e7226f-8827-444a-972b-29fc49494366	Product name	1	20200128

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71336-1001-1	GIVLAARI	1 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	1		14
71336-1001-1	GIVLAARI	1 in 1 CARTON	INJECTION, SOLUTION	1		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71336-1001-1	ML - Milliliter	71336-1001	6c499d3f-81b3-4156-a2cd-793d8751d5e7	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71336-1001	GIVLAARI (GIVOSIRAN SODIUM) INJECTION, SOLUTION [ALNYLAM PHARMACEUTICALS, INC.]	13	Current NDC, Legacy NDC, 2 package rows	20240511_167e663c-11e1-497b-a3fc-951d65d58eaa.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
GIVLAARI	GIVOSIRAN SODIUM	Alnylam Pharmaceuticals, Inc.	167e663c-11e1-497b-a3fc-951d65d58eaa	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212194 application number: NDA212194 ndc (product): 71336-1001

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
5XE21E41RT	GIVOSIRAN SODIUM	GIVOSIRAN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2265721	GIVLAARI 189 MG in 1 ML Injection	PSN	167e663c-11e1-497b-a3fc-951d65d58eaa	14
2265716	givosiran 189 MG in 1 ML Injection	PSN	167e663c-11e1-497b-a3fc-951d65d58eaa	14
2265721	1 ML givosiran 189 MG/ML Injection [Givlaari]	SBD	167e663c-11e1-497b-a3fc-951d65d58eaa	14
2265716	1 ML givosiran 189 MG/ML Injection	SCD	167e663c-11e1-497b-a3fc-951d65d58eaa	14
2265721	1 ML Givlaari 189 MG/ML Injection	SY	167e663c-11e1-497b-a3fc-951d65d58eaa	14
2265721	Givlaari 189 MG per 1 ML Injection	SY	167e663c-11e1-497b-a3fc-951d65d58eaa	14
2265716	givosiran 189 MG per 1 ML Injection	SY	167e663c-11e1-497b-a3fc-951d65d58eaa	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71336-1001-1	71336100101	1 VIAL, SINGLE-USE in 1 CARTON (71336-1001-1) / 1 mL in 1 VIAL, SINGLE-USE	2019-12-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GIVLAARI	Alnylam Pharmaceuticals, Inc. \| PCI San Diego, Inc.	2025-09-10	HUMAN PRESCRIPTION DRUG LABEL	14