Home NDC 81607-018-02 LIRAGLUTIDE
Product NDC 81607-018
Requested package NDC 81607-018-02
11-digit product format 816070018
Labeler code 81607
Product ID 81607-018_a866e2b8-1215-484c-855e-019b12172c97
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LIRAGLUTIDE
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Orbicular Pharmaceutical Technologies Private Limited
Application ANDA217590
Marketing category ANDA
Marketing start 2026-01-21
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 44 .
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 A217590-001 LIRAGLUTIDE LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2026-01-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217590-001 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 2026-10-15 13:18:30 2026-09 A217590-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2026-01-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 A217590-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2026-01-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217590-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2026-01-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217590-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2026-01-14 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217590-001 LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP1 2026-01-14 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 81607-018-01 LIRAGLUTIDE 3 in 1 CARTON INJECTION, SOLUTION 3 1 81607-018-01 LIRAGLUTIDE 3 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 3 1 81607-018-02 LIRAGLUTIDE 2 in 1 CARTON INJECTION, SOLUTION 2 1 81607-018-02 LIRAGLUTIDE 3 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 3 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 81607-018-02 81607001802 2 SYRINGE, PLASTIC in 1 CARTON (81607-018-02) / 3 mL in 1 SYRINGE, PLASTIC 2026-01-21 No No Current