Home NDC 0078-1000 LEQVIO
Product NDC 0078-1000
11-digit product format 000781000
Labeler code 0078
Product ID 0078-1000_596d3b28-0dd7-4e01-9418-0d82372bf854
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name inclisiran
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Novartis Pharmaceuticals Corporation
Application NDA214012
Marketing category NDA
Marketing start 2021-12-22
Substance INCLISIRAN SODIUM
Active strength 284 mg/1.5mL
NDC exclude flag No
Listing certified through 2027-12-31
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 N214012-001 LEQVIO INCLISIRAN SODIUM EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22
Orange Book patents# Current patent rows page 1 of 1 · 26 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214012-001 8809292 2027-05-10 U-4249 Drug substance, Drug product 2022-01-18 N214012-001 8809292 2027-05-10 U-4413 Drug substance, Drug product 2022-01-18 N214012-001 8809292 2027-05-10 U-4414 Drug substance, Drug product 2022-01-18 N214012-001 8222222 2027-12-29 U-4249 2022-01-18 N214012-001 8222222 2027-12-29 U-4413 2022-01-18 N214012-001 8222222 2027-12-29 U-4414 2022-01-18 N214012-001 10131907 2028-08-24 U-4249 Drug substance, Drug product 2022-01-18 N214012-001 10131907 2028-08-24 U-4413 Drug substance, Drug product 2022-01-18 N214012-001 10131907 2028-08-24 U-4414 Drug substance, Drug product 2022-01-18 N214012-001 10806791 2028-12-04 Drug substance 2022-01-18 N214012-001 8828956 2028-12-04 U-4249 Drug substance, Drug product 2022-01-18 N214012-001 8828956 2028-12-04 U-4413 Drug substance, Drug product 2022-01-18 N214012-001 8828956 2028-12-04 U-4414 Drug substance, Drug product 2022-01-18 N214012-001 9370582 2028-12-04 U-4249 Drug substance, Drug product 2022-01-18 N214012-001 9370582 2028-12-04 U-4413 Drug substance, Drug product 2022-01-18 N214012-001 9370582 2028-12-04 U-4414 Drug substance, Drug product 2022-01-18 N214012-001 8106022 2029-12-12 U-4249 Drug substance, Drug product 2022-01-18 N214012-001 8106022 2029-12-12 U-4413 Drug substance, Drug product 2022-01-18 N214012-001 8106022 2029-12-12 U-4414 Drug substance, Drug product 2022-01-18 N214012-001 10125369 2034-08-18 U-4249 Drug substance, Drug product 2022-01-18 N214012-001 10125369 2034-08-18 U-4413 Drug substance, Drug product 2022-01-18 N214012-001 10125369 2034-08-18 U-4414 Drug substance, Drug product 2022-01-18 N214012-001 12460206 2034-08-18 Drug substance, Drug product 2025-11-24 N214012-001 10851377 2036-08-25 U-4249 2022-01-18 N214012-001 10851377 2036-08-25 U-4413 2022-01-18 N214012-001 10851377 2036-08-25 U-4414 2022-01-18
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214012-001 NCE 2026-12-22 N214012-001 I-985 2029-02-12 N214012-001 NPP 2029-02-12
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 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 13 · 489 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 N214012-001 8809292 2027-05-10 U-4249 Drug substance, Drug product 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 8222222 2027-12-29 U-4249 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 10131907 2028-08-24 U-4249 Drug substance, Drug product 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 10806791 2028-12-04 Drug substance 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 8828956 2028-12-04 U-4249 Drug substance, Drug product 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 9370582 2028-12-04 U-4249 Drug substance, Drug product 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 8106022 2029-12-12 U-4249 Drug substance, Drug product 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 10125369 2034-08-18 U-4249 Drug substance, Drug product 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 12460206 2034-08-18 Drug substance, Drug product 2025-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 10851377 2036-08-25 U-4249 2022-01-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214012-001 8809292 2027-05-10 U-4249 Drug substance, Drug product 2022-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214012-001 8222222 2027-12-29 U-4249 2022-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214012-001 10131907 2028-08-24 U-4249 Drug substance, Drug product 2022-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214012-001 10806791 2028-12-04 Drug substance 2022-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214012-001 8828956 2028-12-04 U-4249 Drug substance, Drug product 2022-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214012-001 9370582 2028-12-04 U-4249 Drug substance, Drug product 2022-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214012-001 8106022 2029-12-12 U-4249 Drug substance, Drug product 2022-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214012-001 10125369 2034-08-18 U-4249 Drug substance, Drug product 2022-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214012-001 12460206 2034-08-18 Drug substance, Drug product 2025-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214012-001 10851377 2036-08-25 U-4249 2022-01-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214012-001 8809292 2027-05-10 U-3652 Drug substance, Drug product 2022-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214012-001 8222222 2027-12-29 U-3652 2022-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214012-001 10131907 2028-08-24 U-3652 Drug substance, Drug product 2022-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214012-001 10806791 2028-12-04 Drug substance 2022-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214012-001 8828956 2028-12-04 U-3652 Drug substance, Drug product 2022-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214012-001 9370582 2028-12-04 U-3652 Drug substance, Drug product 2022-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214012-001 8106022 2029-12-12 U-3652 Drug substance, Drug product 2022-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214012-001 10125369 2034-08-18 U-3652 Drug substance, Drug product 2022-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214012-001 10851377 2036-08-25 U-3652 2022-01-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214012-001 8809292 2027-05-10 U-3652 Drug substance, Drug product 2022-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214012-001 8222222 2027-12-29 U-3652 2022-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214012-001 10131907 2028-08-24 U-3652 Drug substance, Drug product 2022-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214012-001 10806791 2028-12-04 Drug substance 2022-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214012-001 8828956 2028-12-04 U-3652 Drug substance, Drug product 2022-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214012-001 9370582 2028-12-04 U-3652 Drug substance, Drug product 2022-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214012-001 8106022 2029-12-12 U-3652 Drug substance, Drug product 2022-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214012-001 10125369 2034-08-18 U-3652 Drug substance, Drug product 2022-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214012-001 10851377 2036-08-25 U-3652 2022-01-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214012-001 8809292 2027-05-10 U-3652 Drug substance, Drug product 2022-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214012-001 8222222 2027-12-29 U-3652 2022-01-18 b8a1b40f171c…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base LEQVIO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INCLISIRAN SODIUM 284 mg/1.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination UPC6BTX7PY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2588263 Internal RxNorm lookup 2588269 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 0078-1000-60 LEQVIO 1.5 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1.5 12 0078-1000-60 LEQVIO 1 in 1 CARTON INJECTION, SOLUTION 1 12 0078-1000-98 LEQVIO 1.5 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1.5 12 0078-1000-98 LEQVIO 1 in 1 CARTON INJECTION, SOLUTION 1 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-1000 LEQVIO (INCLISIRAN) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 9 Current NDC, Legacy NDC, 4 package rows 20240710_6fc0afca-4513-4c35-b594-6544aee29a44.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 LEQVIO INCLISIRAN Novartis Pharmaceuticals Corporation 6fc0afca-4513-4c35-b594-6544aee29a44 2026-02-12 Warnings, Adverse reactions Exact identifier application applno (NDA): 214012 application number: NDA214012 ndc (product): 0078-1000
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 0078-1000-60 00078100060 1 SYRINGE, GLASS in 1 CARTON (0078-1000-60) / 1.5 mL in 1 SYRINGE, GLASS 2021-12-22 0000-00-00 No No Current 0078-1000-98 00078100098 1 SYRINGE, GLASS in 1 CARTON (0078-1000-98) / 1.5 mL in 1 SYRINGE, GLASS 2023-02-17 Yes No Current