Home NDC 70377-094 Liraglutide
Product NDC 70377-094
11-digit product format 703770094
Labeler code 70377
Product ID 70377-094_be87d32a-f1c2-bdd7-6bf8-30dff2d26cc4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name liraglutide
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler Biocon Pharma Inc.
Application ANDA215245
Marketing category ANDA
Marketing start 2026-04-25
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 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 A215245-001 LIRAGLUTIDE LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2026-03-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215245-001 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 A215245-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2026-03-11 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215245-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2026-03-11 a50c72e98297…
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 A215245-001 AP1 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215245-001 AP1 1 a50c72e98297…
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 70377-094-52 Liraglutide 2 in 1 CARTON INJECTION 2 12 70377-094-52 Liraglutide 3 mL in 1 SYRINGE, PLASTIC INJECTION 3 12 70377-094-53 Liraglutide 3 mL in 1 SYRINGE, PLASTIC INJECTION 3 12 70377-094-53 Liraglutide 3 in 1 CARTON INJECTION 3 12
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70377-094-52 70377009452 2 SYRINGE, PLASTIC in 1 CARTON (70377-094-52) / 3 mL in 1 SYRINGE, PLASTIC 2026-04-25 No No Current 70377-094-53 70377009453 3 SYRINGE, PLASTIC in 1 CARTON (70377-094-53) / 3 mL in 1 SYRINGE, PLASTIC 2026-04-25 No No Current