Home NDC 71336-1001 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 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 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 Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N212194-001 GIVLAARI EQ 189MG BASE/ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-11-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212194-001 GIVLAARI EQ 189MG BASE/ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2019-11-20 caaa826d4ba7…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 12 · 455 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 N212194-001 10131907 2028-08-24 U-2672 Drug substance, Drug product 2019-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212194-001 8828956 2028-12-04 U-2672 Drug substance, Drug product 2019-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212194-001 8106022 2029-12-12 U-2672 Drug substance, Drug product 2019-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212194-001 10125364 2033-03-15 U-2672 Drug substance, Drug product 2019-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212194-001 9631193 2033-03-15 U-2672 2019-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212194-001 9133461 2033-11-30 U-2672 Drug substance, Drug product 2019-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212194-001 10119143 2034-10-03 U-2672 Drug substance, Drug product 2019-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212194-001 11028392 2034-10-03 U-2672 Drug substance, Drug product 2022-02-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212194-001 10131907 2028-08-24 U-2672 Drug substance, Drug product 2019-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212194-001 8828956 2028-12-04 U-2672 Drug substance, Drug product 2019-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212194-001 8106022 2029-12-12 U-2672 Drug substance, Drug product 2019-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212194-001 10125364 2033-03-15 U-2672 Drug substance, Drug product 2019-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212194-001 9631193 2033-03-15 U-2672 2019-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212194-001 9133461 2033-11-30 U-2672 Drug substance, Drug product 2019-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212194-001 10119143 2034-10-03 U-2672 Drug substance, Drug product 2019-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212194-001 11028392 2034-10-03 U-2672 Drug substance, Drug product 2022-02-16 caaa826d4ba7…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 71 observed states.
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.
DailyMed Product Concepts# 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 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.
DailyMed RxNorm Mappings# 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