Home NDC 71336-1000 Onpattro
Product NDC 71336-1000
11-digit product format 713361000
Labeler code 71336
Product ID 71336-1000_254d330d-6f47-45c4-9774-95864ab46941
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name patisiran
Dosage form INJECTION, LIPID COMPLEX
Route INTRAVENOUS
Labeler Alnylam Pharmaceuticals, Inc.
Application NDA210922
Marketing category NDA
Marketing start 2018-08-13
Substance PATISIRAN SODIUM
Active strength 2 mg/mL
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 N210922-001 ONPATTRO PATISIRAN SODIUM EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10
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 N210922-001 8642076 2027-10-03 Drug product 2018-09-06 N210922-001 11141378 2029-04-15 Drug product 2021-11-09 N210922-001 8058069 2029-04-15 Drug product 2018-09-06 N210922-001 8492359 2029-04-15 Drug product 2018-09-06 N210922-001 8822668 2029-04-15 U-2378 Drug product 2018-09-06 N210922-001 9364435 2029-04-15 U-2378 Drug product 2018-09-06 N210922-001 10240152 2029-10-20 U-2378 Drug substance, Drug product 2021-09-03 N210922-001 8741866 2029-10-20 U-2378 2018-09-06 N210922-001 9234196 2029-10-20 U-2378 Drug product 2018-09-06 N210922-001 8802644 2030-10-21 U-2378 Drug product 2018-09-06 N210922-001 8158601 2030-11-10 U-2378 Drug product 2018-09-06 N210922-001 8168775 2032-08-10 U-2378 Drug substance, Drug product 2018-09-06 N210922-001 11079379 2035-08-27 U-2378 Drug substance, Drug product 2021-09-03
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210922-001 M-270 2026-01-13
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 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210922-001 ONPATTRO EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-08-10 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 17 · 668 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 N210922-001 8642076 2027-10-03 Drug product 2018-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210922-001 11141378 2029-04-15 Drug product 2021-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210922-001 8058069 2029-04-15 Drug product 2018-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210922-001 8492359 2029-04-15 Drug product 2018-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210922-001 8822668 2029-04-15 U-2378 Drug product 2018-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210922-001 9364435 2029-04-15 U-2378 Drug product 2018-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210922-001 10240152 2029-10-20 U-2378 Drug substance, Drug product 2021-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210922-001 8741866 2029-10-20 U-2378 2018-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210922-001 9234196 2029-10-20 U-2378 Drug product 2018-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210922-001 8802644 2030-10-21 U-2378 Drug product 2018-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210922-001 8158601 2030-11-10 U-2378 Drug product 2018-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210922-001 8168775 2032-08-10 U-2378 Drug substance, Drug product 2018-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210922-001 11079379 2035-08-27 U-2378 Drug substance, Drug product 2021-09-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210922-001 8334373 2025-05-27 Drug substance, Drug product 2018-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210922-001 8642076 2027-10-03 Drug product 2018-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210922-001 11141378 2029-04-15 Drug product 2021-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210922-001 8058069 2029-04-15 Drug product 2018-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210922-001 8492359 2029-04-15 Drug product 2018-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210922-001 8822668 2029-04-15 U-2378 Drug product 2018-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210922-001 9364435 2029-04-15 U-2378 Drug product 2018-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210922-001 10240152 2029-10-20 U-2378 Drug substance, Drug product 2021-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210922-001 8741866 2029-10-20 U-2378 2018-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210922-001 9234196 2029-10-20 U-2378 Drug product 2018-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210922-001 8802644 2030-10-21 U-2378 Drug product 2018-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210922-001 8158601 2030-11-10 U-2378 Drug product 2018-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210922-001 8168775 2032-08-10 U-2378 Drug substance, Drug product 2018-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210922-001 11079379 2035-08-27 U-2378 Drug substance, Drug product 2021-09-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210922-001 8334373 2025-05-27 Drug substance, Drug product 2018-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210922-001 8642076 2027-10-03 Drug product 2018-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210922-001 11141378 2029-04-15 Drug product 2021-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210922-001 8058069 2029-04-15 Drug product 2018-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210922-001 8492359 2029-04-15 Drug product 2018-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210922-001 8822668 2029-04-15 U-2378 Drug product 2018-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210922-001 9364435 2029-04-15 U-2378 Drug product 2018-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210922-001 10240152 2029-10-20 U-2378 Drug substance, Drug product 2021-09-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210922-001 8741866 2029-10-20 U-2378 2018-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210922-001 9234196 2029-10-20 U-2378 Drug product 2018-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210922-001 8802644 2030-10-21 U-2378 Drug product 2018-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210922-001 8158601 2030-11-10 U-2378 Drug product 2018-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210922-001 8168775 2032-08-10 U-2378 Drug substance, Drug product 2018-09-06 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 75 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Onpattro
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PATISIRAN SODIUM 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WO0YM16LKG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2053524 Internal RxNorm lookup 2053529 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 71336-1000-1 Onpattro 1 in 1 CARTON INJECTION, LIPID COMPLEX 1 11 71336-1000-1 Onpattro 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, LIPID COMPLEX 5 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71336-1000 ONPATTRO (PATISIRAN) INJECTION, LIPID COMPLEX [ALNYLAM PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20230126_e87ec36f-b4b4-49d4-aea4-d4ffb09b0970.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 71336-1000-1 71336100001 1 VIAL, SINGLE-DOSE in 1 CARTON (71336-1000-1) / 5 mL in 1 VIAL, SINGLE-DOSE 2018-08-13 0000-00-00 No No Current