Home NDC 50090-4503 Victoza
Product NDC 50090-4503
11-digit product format 500904503
Labeler code 50090
Product ID 50090-4503_a934a344-0ee2-420c-980c-ae69581875fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name liraglutide
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler A-S Medication Solutions
Application NDA022341
Marketing category NDA
Marketing start 2010-01-25
Substance LIRAGLUTIDE
Active strength 6 mg/mL
Pharmacologic classes GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
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 42 .
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 N022341-001 VICTOZA LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 RLD, RS 2010-01-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022341-001 AP1
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022341-001 8114833 2025-08-13 Drug substance, Drug product 2012-03-13 N022341-001 8114833*PED 2026-02-13 Pediatric extension N022341-001 9968659 2037-01-09 U-2313 2018-06-12 N022341-001 9968659*PED 2037-07-09 Pediatric extension
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 · 42 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 2026-08-18 06:07:40 2026-07 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 RLD, RS 2010-01-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 RLD, RS 2010-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 RLD, RS 2010-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2010-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022341-001 VICTOZA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2010-01-25 e64feba35796…
Observed Orange Book normalized TE history# 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 2026-08-18 06:07:40 2026-07 N022341-001 8114833 2025-08-13 Drug substance, Drug product 2012-03-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022341-001 8114833*PED 2026-02-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022341-001 9968659 2037-01-09 U-2313 2018-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022341-001 9968659*PED 2037-07-09 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022341-001 8114833 2025-08-13 Drug substance, Drug product 2012-03-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022341-001 8114833*PED 2026-02-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022341-001 9968659 2037-01-09 U-2313 2018-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022341-001 9968659*PED 2037-07-09 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022341-001 8114833 2025-08-13 Drug substance, Drug product 2012-03-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022341-001 8114833*PED 2026-02-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022341-001 9968659 2037-01-09 U-2313 2018-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022341-001 9968659*PED 2037-07-09 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022341-001 8114833 2025-08-13 Drug substance, Drug product 2012-03-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022341-001 8114833*PED 2026-02-13 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022341-001 9968659 2037-01-09 U-2313 2018-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022341-001 9968659*PED 2037-07-09 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022341-001 8114833 2025-08-13 Drug substance, Drug product 2012-03-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022341-001 8114833*PED 2026-02-13 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022341-001 9265893 2032-09-23 Drug product 2016-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022341-001 9265893*PED 2033-03-23 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022341-001 9968659 2037-01-09 U-2313 2018-06-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022341-001 9968659*PED 2037-07-09 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022341-001 8114833 2025-08-13 Drug substance, Drug product 2012-03-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022341-001 8114833*PED 2026-02-13 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022341-001 9265893 2032-09-23 Drug product 2016-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022341-001 9265893*PED 2033-03-23 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022341-001 9968659 2037-01-09 U-2313 2018-06-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022341-001 9968659*PED 2037-07-09 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022341-001 7762994 2024-05-23 Drug product 2019-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022341-001 7762994*PED 2024-11-23 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022341-001 8114833 2025-08-13 Drug substance, Drug product 2012-03-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022341-001 8114833*PED 2026-02-13 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022341-001 9265893 2032-09-23 Drug product 2016-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022341-001 9265893*PED 2033-03-23 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022341-001 9968659 2037-01-09 U-2313 2018-06-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022341-001 9968659*PED 2037-07-09 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022341-001 7762994 2024-05-23 Drug product 2019-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022341-001 7762994*PED 2024-11-23 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022341-001 8114833 2025-08-13 Drug substance, Drug product 2012-03-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022341-001 8114833*PED 2026-02-13 Pediatric extension 2680178bc6a6…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 46 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Victoza
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIRAGLUTIDE 6 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 839I73S42A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 897122 Internal RxNorm lookup 897126 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-4503-0 Victoza 3 mL in 1 SYRINGE, PLASTIC INJECTION 3 5 50090-4503-0 Victoza 3 in 1 CARTON INJECTION 3 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4503 VICTOZA (LIRAGLUTIDE) INJECTION [A-S MEDICATION SOLUTIONS] 5 Current NDC, Legacy NDC, 2 package rows 20230208_35e613e3-7aae-4152-b827-99d1ee7841be.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Liraglutide LIRAGLUTIDE Teva Pharmaceuticals USA, Inc. 14bf9812-14ee-46ce-93b1-686e4906cbbc 2026-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022341 application number: NDA022341 Victoza LIRAGLUTIDE Novo Nordisk 5a9ef4ea-c76a-4d34-a604-27c5b505f5a4 2025-10-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022341 application number: NDA022341 Liraglutide LIRAGLUTIDE A-S Medication Solutions 0ba917f7-b974-4364-a745-7494ecae3e73 2025-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022341 application number: NDA022341 Victoza LIRAGLUTIDE A-S Medication Solutions 1d18f106-0584-4fee-97ab-32771a64b809 2023-02-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022341 application number: NDA022341 Victoza LIRAGLUTIDE A-S Medication Solutions 35e613e3-7aae-4152-b827-99d1ee7841be 2023-02-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022341 application number: NDA022341 ndc (product): 50090-4503
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 50090-4503-0 50090450300 3 SYRINGE, PLASTIC in 1 CARTON (50090-4503-0) / 3 mL in 1 SYRINGE, PLASTIC 2019-09-04 0000-00-00 No No Current