Home NDC 71336-1002 OXLUMO
Product NDC 71336-1002
11-digit product format 713361002
Labeler code 71336
Product ID 71336-1002_6ef869cb-8ccd-4339-9991-0fab45da1fbd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lumasiran
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Alnylam Pharmaceuticals, Inc.
Application NDA214103
Marketing category NDA
Marketing start 2020-11-23
Substance LUMASIRAN SODIUM
Active strength 94.5 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 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 N214103-001 OXLUMO LUMASIRAN SODIUM EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214103-001 10131907 2028-08-24 U-2995 Drug substance, Drug product 2020-12-10 N214103-001 8828956 2028-12-04 U-2995 Drug substance, Drug product 2020-12-10 N214103-001 8106022 2029-12-12 U-2995 Drug substance, Drug product 2020-12-10 N214103-001 10435692 2034-12-26 U-2995 2020-12-10 N214103-001 10465195 2034-12-26 U-2995 Drug substance, Drug product 2020-12-10 N214103-001 10487330 2034-12-26 U-2995 Drug substance, Drug product 2020-12-10 N214103-001 11060093 2034-12-26 U-2995 Drug substance, Drug product 2021-08-17 N214103-001 9828606 2034-12-26 Drug substance, Drug product 2020-12-10 N214103-001 10612024 2035-08-14 U-2995 Drug substance, Drug product 2020-12-10 N214103-001 10612027 2035-08-14 U-2995 Drug substance, Drug product 2020-12-10 N214103-001 11401517 2035-08-14 U-2995 Drug substance, Drug product 2022-09-19 N214103-001 10478500 2035-10-09 U-2995 Drug substance, Drug product 2020-12-10 N214103-001 11446380 2035-10-09 Drug substance, Drug product 2022-10-19 N214103-001 11261447 2038-11-20 U-2995 Drug substance, Drug product 2022-03-17
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214103-001 ODE-339 2027-11-23 N214103-001 ODE-415 2029-10-06
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 2026-02-19 14:30 UTC 2026-02 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214103-001 OXLUMO EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214103-001 OXLUMO EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214103-001 OXLUMO EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214103-001 OXLUMO EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214103-001 OXLUMO EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214103-001 OXLUMO EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N214103-001 OXLUMO EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N214103-001 OXLUMO EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214103-001 OXLUMO EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214103-001 OXLUMO EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214103-001 OXLUMO EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214103-001 OXLUMO EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214103-001 OXLUMO EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214103-001 OXLUMO EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214103-001 OXLUMO EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214103-001 OXLUMO EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214103-001 OXLUMO EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2020-11-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 12 · 464 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 N214103-001 10131907 2028-08-24 U-2995 Drug substance, Drug product 2020-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214103-001 8828956 2028-12-04 U-2995 Drug substance, Drug product 2020-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214103-001 8106022 2029-12-12 U-2995 Drug substance, Drug product 2020-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214103-001 10435692 2034-12-26 U-2995 2020-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214103-001 10465195 2034-12-26 U-2995 Drug substance, Drug product 2020-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214103-001 10487330 2034-12-26 U-2995 Drug substance, Drug product 2020-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214103-001 11060093 2034-12-26 U-2995 Drug substance, Drug product 2021-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214103-001 9828606 2034-12-26 Drug substance, Drug product 2020-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214103-001 10612024 2035-08-14 U-2995 Drug substance, Drug product 2020-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214103-001 10612027 2035-08-14 U-2995 Drug substance, Drug product 2020-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214103-001 11401517 2035-08-14 U-2995 Drug substance, Drug product 2022-09-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214103-001 10478500 2035-10-09 U-2995 Drug substance, Drug product 2020-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214103-001 11446380 2035-10-09 Drug substance, Drug product 2022-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214103-001 11261447 2038-11-20 U-2995 Drug substance, Drug product 2022-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214103-001 10131907 2028-08-24 U-2995 Drug substance, Drug product 2020-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214103-001 8828956 2028-12-04 U-2995 Drug substance, Drug product 2020-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214103-001 8106022 2029-12-12 U-2995 Drug substance, Drug product 2020-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214103-001 10435692 2034-12-26 U-2995 2020-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214103-001 10465195 2034-12-26 U-2995 Drug substance, Drug product 2020-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214103-001 10487330 2034-12-26 U-2995 Drug substance, Drug product 2020-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214103-001 11060093 2034-12-26 U-2995 Drug substance, Drug product 2021-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214103-001 9828606 2034-12-26 Drug substance, Drug product 2020-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214103-001 10612024 2035-08-14 U-2995 Drug substance, Drug product 2020-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214103-001 10612027 2035-08-14 U-2995 Drug substance, Drug product 2020-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214103-001 11401517 2035-08-14 U-2995 Drug substance, Drug product 2022-09-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214103-001 10478500 2035-10-09 U-2995 Drug substance, Drug product 2020-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214103-001 11446380 2035-10-09 Drug substance, Drug product 2022-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214103-001 11261447 2038-11-20 U-2995 Drug substance, Drug product 2022-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214103-001 10131907 2028-08-24 U-2995 Drug substance, Drug product 2020-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214103-001 8828956 2028-12-04 U-2995 Drug substance, Drug product 2020-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214103-001 8106022 2029-12-12 U-2995 Drug substance, Drug product 2020-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214103-001 10435692 2034-12-26 U-2995 2020-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214103-001 10465195 2034-12-26 U-2995 Drug substance, Drug product 2020-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214103-001 10487330 2034-12-26 U-2995 Drug substance, Drug product 2020-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214103-001 11060093 2034-12-26 U-2995 Drug substance, Drug product 2021-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214103-001 9828606 2034-12-26 Drug substance, Drug product 2020-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214103-001 10612024 2035-08-14 U-2995 Drug substance, Drug product 2020-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214103-001 10612027 2035-08-14 U-2995 Drug substance, Drug product 2020-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214103-001 11401517 2035-08-14 U-2995 Drug substance, Drug product 2022-09-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214103-001 10478500 2035-10-09 U-2995 Drug substance, Drug product 2020-12-10 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 111 observed states.
Additional Listing Data#
Finished product Yes
Brand name base OXLUMO
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LUMASIRAN SODIUM 94.5 mg/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 67P6XH37HD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2467153 Internal RxNorm lookup 2467158 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 71336-1002-1 OXLUMO 1 in 1 CARTON INJECTION, SOLUTION 1 9 71336-1002-1 OXLUMO 0.5 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 0.5 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71336-1002 OXLUMO (LUMASIRAN) INJECTION, SOLUTION [ALNYLAM PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20250412_16985a31-f5e4-4557-9266-fc78d4bc5055.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 71336-1002-1 71336100201 1 VIAL, SINGLE-USE in 1 CARTON (71336-1002-1) / .5 mL in 1 VIAL, SINGLE-USE 2020-11-23 0000-00-00 No No Current