FDA.reportPublic FDA data

Liraglutide

Product NDC
0480-3667
11-digit product format
004803667
Labeler code
0480
Product ID
0480-3667_57c9f463-a1b8-4efa-8982-40175cf6cf4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
liraglutide
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Teva Pharmaceuticals USA, Inc.
Application
NDA022341
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-06-24
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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2f360a13-6ea8-4c2b-b2ef-10133c2836d9Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-3667-19Liraglutide3 mL in 1 SYRINGE, PLASTICINJECTION33
0480-3667-20Liraglutide2 in 1 CARTONINJECTION23
0480-3667-22Liraglutide3 in 1 CARTONINJECTION33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-3667-19ML - Milliliter0480-366759366080-d319-4588-8a16-2ec1d74075f512024-07-12
0480-3667-20ML - Milliliter0480-3667f4e22da3-8fe9-4ac3-8f0a-8fec9f6324a412024-07-12
0480-3667-22ML - Milliliter0480-3667c1694ee9-b187-4fea-b089-48927f0e838e12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-3667LIRAGLUTIDE INJECTION [TEVA PHARMACEUTICALS USA, INC.]2Current NDC, 3 package rows20240625_14bf9812-14ee-46ce-93b1-686e4906cbbc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897122liraglutide 6 MG/ML in 3 ML Pen InjectorPSN14bf9812-14ee-46ce-93b1-686e4906cbbc3
8971223 ML liraglutide 6 MG/ML Pen InjectorSCD14bf9812-14ee-46ce-93b1-686e4906cbbc3
897122liraglutide 18 MG per 3 ML Pen InjectorSY14bf9812-14ee-46ce-93b1-686e4906cbbc3
897122liraglutide 6 MG/ML in 3 ML Pen InjectorPSN0ba917f7-b974-4364-a745-7494ecae3e731
8971223 ML liraglutide 6 MG/ML Pen InjectorSCD0ba917f7-b974-4364-a745-7494ecae3e731
897122liraglutide 18 MG per 3 ML Pen InjectorSY0ba917f7-b974-4364-a745-7494ecae3e731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0480-3667-19004803667193 mL in 1 SYRINGE, PLASTIC3 mlHistorical
0480-3667-20004803667202 SYRINGE, PLASTIC in 1 CARTON (0480-3667-20) / 3 mL in 1 SYRINGE, PLASTIC (0480-3667-19) 2024-06-24NoNoCurrent
0480-3667-22004803667223 SYRINGE, PLASTIC in 1 CARTON (0480-3667-22) / 3 mL in 1 SYRINGE, PLASTIC (0480-3667-19) 2024-06-24NoNoCurrent