Home NDC 0169-2800 Saxenda
Product NDC 0169-2800
11-digit product format 001692800
Labeler code 0169
Product ID 0169-2800_eba7f5c9-44d0-4549-ae94-daa2c5181646
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name liraglutide
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Novo Nordisk
Application NDA206321
Marketing category NDA
Marketing start 2014-12-31
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 2027-12-31
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 N206321-001 SAXENDA LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP2 RLD, RS 2014-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N206321-001 AP2
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 N206321-001 8114833 2025-08-13 Drug product 2015-01-21 N206321-001 8114833*PED 2026-02-13 Pediatric extension N206321-001 9968659 2037-01-09 U-2438 2018-11-16 N206321-001 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 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP2 RLD, RS 2014-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP2 RLD, RS 2014-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP2 RLD, RS 2014-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 e64feba35796…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 N206321-001 AP2 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206321-001 AP2 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206321-001 AP2 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N206321-001 AP2 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 36 · 1,424 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 N206321-001 8114833 2025-08-13 Drug product 2015-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206321-001 8114833*PED 2026-02-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206321-001 9968659 2037-01-09 U-2438 2018-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206321-001 9968659*PED 2037-07-09 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206321-001 8114833 2025-08-13 Drug product 2015-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206321-001 8114833*PED 2026-02-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206321-001 9968659 2037-01-09 U-2438 2018-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206321-001 9968659*PED 2037-07-09 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206321-001 8114833 2025-08-13 Drug product 2015-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206321-001 8114833*PED 2026-02-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206321-001 9968659 2037-01-09 U-2438 2018-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206321-001 9968659*PED 2037-07-09 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206321-001 8114833 2025-08-13 Drug product 2015-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206321-001 8114833*PED 2026-02-13 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206321-001 9968659 2037-01-09 U-2438 2018-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206321-001 9968659*PED 2037-07-09 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 8114833 2025-08-13 Drug product 2015-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 11446443 2025-10-20 Drug product 2022-10-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 8684969 2025-10-20 Drug product 2015-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 10357616 2026-01-20 Drug product 2019-08-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 10376652 2026-01-20 Drug product 2019-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 11311679 2026-01-20 Drug product 2022-05-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9616180 2026-01-20 Drug product 2018-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9861757 2026-01-20 Drug product 2018-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9108002 2026-01-26 Drug product 2015-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 8114833*PED 2026-02-13 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 8684969*PED 2026-04-20 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 10220155 2026-07-17 Drug product 2019-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 11097063 2026-07-17 Drug product 2021-09-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 8920383 2026-07-17 Drug product 2015-02-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9775953 2026-07-17 Drug product 2017-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9616180*PED 2026-07-20 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9861757*PED 2026-07-20 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9108002*PED 2026-07-26 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 RE46363 2026-08-03 Drug product 2017-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 10220155*PED 2027-01-17 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 8920383*PED 2027-01-17 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9775953*PED 2027-01-17 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 RE46363*PED 2027-02-03 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9687611 2027-02-27 Drug product 2017-09-06 fd3edfee7708…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Saxenda
Listing expiration 2027-12-31 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 1598268 Internal RxNorm lookup 2735350 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 0169-2800-15 Saxenda 3 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 3 21 0169-2800-15 Saxenda 5 in 1 CARTON INJECTION, SOLUTION 5 21 0169-2800-90 Saxenda 3 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 3 21 0169-2800-90 Saxenda 1 in 1 CARTON INJECTION, SOLUTION 1 21 0169-2800-97 Saxenda 1 in 1 CARTON INJECTION, SOLUTION 1 21 0169-2800-97 Saxenda 3 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 3 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LIRAGLUTIDE ACTIVE INGREDIENT 839I73S42A SAXENDA (LIRAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK] 4 LIRAGLUTIDE ACTIVE MOIETY 839I73S42A SAXENDA (LIRAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK] 4 PHENOL INACTIVE INGREDIENT 339NCG44TV SAXENDA (LIRAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SAXENDA (LIRAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK] 4 SODIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT 94255I6E2T SAXENDA (LIRAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK] 4 WATER INACTIVE INGREDIENT 059QF0KO0R SAXENDA (LIRAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0169-2800 SAXENDA (LIRAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK] 18 Current NDC, Legacy NDC, 6 package rows 20241115_3946d389-0926-4f77-a708-0acb8153b143.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 · 2 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 0169-2800-15 00169280015 5 SYRINGE, PLASTIC in 1 CARTON (0169-2800-15) / 3 mL in 1 SYRINGE, PLASTIC 2015-01-19 0000-00-00 No No Current 0169-2800-90 00169280090 1 SYRINGE, PLASTIC in 1 CARTON (0169-2800-90) / 3 mL in 1 SYRINGE, PLASTIC 2015-01-19 0000-00-00 No No Current 0169-2800-97 00169280097 1 SYRINGE, PLASTIC in 1 CARTON (0169-2800-97) / 3 mL in 1 SYRINGE, PLASTIC 2015-01-19 0000-00-00 No No Current