Home NDC 70748-346 Liraglutide
Product NDC 70748-346
11-digit product format 707480346
Labeler code 70748
Product ID 70748-346_a38eca16-ef6d-40e4-8b6e-d62cd581f15e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Liraglutide
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA215421
Marketing category ANDA
Marketing start 2025-10-02
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 45 .
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 A215421-001 LIRAGLUTIDE LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2025-07-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215421-001 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 2026-11-14 07:37:17 2026-10 A215421-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2025-07-22 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A215421-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2025-07-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A215421-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2025-07-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215421-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2025-07-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215421-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2025-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215421-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2025-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215421-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP 2025-07-22 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215421-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2025-07-22 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Liraglutide
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 · 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 70748-346-02 Liraglutide 3 mL in 1 SYRINGE, PLASTIC INJECTION 3 10 70748-346-02 Liraglutide 2 in 1 CARTON INJECTION 2 10 70748-346-03 Liraglutide 3 mL in 1 SYRINGE, PLASTIC INJECTION 3 10 70748-346-03 Liraglutide 3 in 1 CARTON INJECTION 3 10
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70748-346-02 70748034602 2 SYRINGE, PLASTIC in 1 CARTON (70748-346-02) / 3 mL in 1 SYRINGE, PLASTIC 2025-10-02 No No Current 70748-346-03 70748034603 3 SYRINGE, PLASTIC in 1 CARTON (70748-346-03) / 3 mL in 1 SYRINGE, PLASTIC 2025-10-02 No No Current