FDA.reportPublic FDA data

LANREOTIDE ACETATE

Product NDC
76282-718
11-digit product format
762820718
Labeler code
76282
Product ID
76282-718_054af266-c850-45c8-b027-d810d7d5f0ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LANREOTIDE ACETATE
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
EXELAN PHARMACEUTICALS, INC.
Application
ANDA217193
Marketing category
ANDA
Marketing start
2025-05-30
Substance
LANREOTIDE ACETATE
Active strength
60 mg/.2mL
Pharmacologic classes
Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LANREOTIDE ACETATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANREOTIDE ACETATE60 mg/.2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIEU56G3J9C
Rxcui749811, 749814, 749817

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3340e9ad-5e0e-4ddc-aa91-4357df39a30fProduct name220250221
e9869da2-9f36-4263-93de-4156429775d7Product name120220720
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-718-67LANREOTIDE ACETATE1 in 1 CARTONINJECTION12
76282-718-67LANREOTIDE ACETATE1 in 1 POUCHINJECTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-718LANREOTIDE ACETATE INJECTION [EXELAN PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20240601_eec3c37e-83a7-4195-bccf-cd5973459eef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749814lanreotide 120 MG in 0.5 ML Prefilled SyringePSNeec3c37e-83a7-4195-bccf-cd5973459eef2
749811lanreotide 60 MG in 0.2 ML Prefilled SyringePSNeec3c37e-83a7-4195-bccf-cd5973459eef2
749817lanreotide 90 MG in 0.3 ML Prefilled SyringePSNeec3c37e-83a7-4195-bccf-cd5973459eef2
7498110.2 ML lanreotide 300 MG/ML Prefilled SyringeSCDeec3c37e-83a7-4195-bccf-cd5973459eef2
7498170.3 ML lanreotide 300 MG/ML Prefilled SyringeSCDeec3c37e-83a7-4195-bccf-cd5973459eef2
7498140.5 ML lanreotide 240 MG/ML Prefilled SyringeSCDeec3c37e-83a7-4195-bccf-cd5973459eef2
7498140.5 ML lanreotide 240 MG/ML (as lanreotide acetate) Prefilled SyringeSYeec3c37e-83a7-4195-bccf-cd5973459eef2
749814lanreotide 120 MG per 0.5 ML Prefilled SyringeSYeec3c37e-83a7-4195-bccf-cd5973459eef2
749811lanreotide 60 MG per 0.2 ML (as lanreotide acetate) Prefilled SyringeSYeec3c37e-83a7-4195-bccf-cd5973459eef2
749817lanreotide 90 MG per 0.3 ML (as lanreotide acetate) Prefilled SyringeSYeec3c37e-83a7-4195-bccf-cd5973459eef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76282-718-67762820718671 POUCH in 1 CARTON (76282-718-67) / 1 SYRINGE in 1 POUCH / .2 mL in 1 SYRINGE1 pouch2025-05-30NoNoCurrent