Home NDC 14403-3400 Liraglutide
Product NDC 14403-3400
11-digit product format 144033400
Labeler code 14403
Product ID 14403-3400_1a36a385-111a-f5a9-e063-6294a90a29a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Liraglutide
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Hybio Pharmaceutical Co., Ltd. (Pingshan Factory)
Application ANDA215503
Marketing category ANDA
Marketing start 2024-06-21
Substance LIRAGLUTIDE
Active strength 18 mg/3mL
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 A215503-001 LIRAGLUTIDE LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2024-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215503-001 AP1
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 2026-08-18 06:07:40 2026-07 A215503-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2024-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215503-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2024-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215503-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2024-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215503-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215503-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215503-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215503-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-12-23 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215503-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2024-12-23 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Liraglutide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIRAGLUTIDE 18 mg/3mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 897122 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 14403-3400-1 Liraglutide 3 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 3 4 14403-3400-2 Liraglutide 2 in 1 CARTON INJECTION, SOLUTION 2 4 14403-3400-1 Liraglutide 3 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 3 3 14403-3400-3 Liraglutide 3 in 1 CARTON INJECTION, SOLUTION 3 3 14403-3400-1 Liraglutide 3 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 3 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 14403-3400 LIRAGLUTIDE INJECTION, SOLUTION [HYBIO PHARMACEUTICAL CO., LTD. (PINGSHAN FACTORY)] 4 Current NDC, 2 package rows 20241225_1a372465-d56b-2b80-e063-6394a90a3304.zip 14403-3400 LIRAGLUTIDE INJECTION, SOLUTION [HYBIO PHARMACEUTICAL CO., LTD. (PINGSHAN FACTORY)] 3 Current NDC, 2 package rows 20241225_1a36f43f-d734-97cc-e063-6294a90ae0da.zip 14403-3400 LIRAGLUTIDE INJECTION, SOLUTION [HYBIO PHARMACEUTICAL CO., LTD. (PINGSHAN FACTORY)] 1 Current NDC, 1 package rows 20241224_1a36b801-41e2-2eed-e063-6294a90a6f27.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Liraglutide LIRAGLUTIDE Hikma Pharmaceuticals USA Inc. 2100ec49-57b2-4330-ab5f-057ce9b7e4d0 2026-05-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215503 application number: ANDA215503 Liraglutide LIRAGLUTIDE Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) 1a372465-d56b-2b80-e063-6394a90a3304 2024-12-03 Warnings, Adverse reactions Exact identifier application applno (ANDA): 215503 application number: ANDA215503 ndc (product): 14403-3400 Liraglutide LIRAGLUTIDE Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) 1a36f43f-d734-97cc-e063-6294a90ae0da 2024-12-02 Warnings, Adverse reactions Exact identifier application applno (ANDA): 215503 application number: ANDA215503 ndc (product): 14403-3400 Liraglutide LIRAGLUTIDE Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) 1a36b801-41e2-2eed-e063-6294a90a6f27 2024-06-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 215503 application number: ANDA215503 ndc (product): 14403-3400
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 14403-3400-1 14403340001 3 mL in 1 SYRINGE, PLASTIC (14403-3400-1) 3 ml 2024-06-21 No No Current 14403-3400-2 14403340002 2 SYRINGE, PLASTIC in 1 CARTON (14403-3400-2) / 3 mL in 1 SYRINGE, PLASTIC (14403-3400-1) 2024-12-24 No No Current 14403-3400-3 14403340003 3 SYRINGE, PLASTIC in 1 CARTON (14403-3400-3) / 3 mL in 1 SYRINGE, PLASTIC (14403-3400-1) 2024-12-24 No No Current