FDA.reportPublic FDA data

LIRAGLUTIDE

Product NDC
81607-018
11-digit product format
816070018
Labeler code
81607
Product ID
81607-018_026b3564-4bf1-4f85-b7c7-abd03c8d9c3d
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

Additional Listing Data#

Finished product
Yes
Brand name base
LIRAGLUTIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIRAGLUTIDE6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii839I73S42A
Rxcui897122

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d8dac6c8-0045-42cf-b357-c3350b4ada5cProduct name220251021
0dd952e2-ff48-4739-9b8d-72ae0b326834Product name220200323
ce962b7e-f9f8-43e6-8d30-41514e79f3e4Product name120190201
2f360a13-6ea8-4c2b-b2ef-10133c2836d9Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81607-018-01LIRAGLUTIDE3 in 1 CARTONINJECTION, SOLUTION31
81607-018-01LIRAGLUTIDE3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION31
81607-018-02LIRAGLUTIDE2 in 1 CARTONINJECTION, SOLUTION21
81607-018-02LIRAGLUTIDE3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION31

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897122liraglutide 6 MG/ML in 3 ML Pen InjectorPSNbb66a46c-9019-4a98-8e5d-581109facfba1
8971223 ML liraglutide 6 MG/ML Pen InjectorSCDbb66a46c-9019-4a98-8e5d-581109facfba1
897122liraglutide 18 MG per 3 ML Pen InjectorSYbb66a46c-9019-4a98-8e5d-581109facfba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81607-018-01816070018013 SYRINGE, PLASTIC in 1 CARTON (81607-018-01) / 3 mL in 1 SYRINGE, PLASTIC2026-01-21NoNoHistorical
81607-018-02816070018022 SYRINGE, PLASTIC in 1 CARTON (81607-018-02) / 3 mL in 1 SYRINGE, PLASTIC2026-01-21NoNoHistorical