FDA.reportPublic FDA data

LANREOTIDE ACETATE

Product NDC
69097-906
11-digit product format
690970906
Labeler code
69097
Product ID
69097-906_6d47aa22-362a-4663-8b98-a16c4ff0607a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LANREOTIDE ACETATE
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Cipla USA Inc.
Application
ANDA217193
Marketing category
ANDA
Marketing start
2025-05-30
Substance
LANREOTIDE ACETATE
Active strength
120 mg/.5mL
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 ACETATE120 mg/.5mL

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
69097-906-67LANREOTIDE ACETATE1 in 1 CARTONINJECTION13
69097-906-67LANREOTIDE ACETATE1 in 1 POUCHINJECTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-906-67ML - Milliliter69097-906969d4b1d-725f-4169-a69c-0c7a9871d3a712024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-906LANREOTIDE ACETATE INJECTION [CIPLA USA INC.]2Current NDC, 2 package rows20241129_2892b4c3-0329-4d29-97ff-3b45283bbab1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749814lanreotide 120 MG in 0.5 ML Prefilled SyringePSN2892b4c3-0329-4d29-97ff-3b45283bbab13
749811lanreotide 60 MG in 0.2 ML Prefilled SyringePSN2892b4c3-0329-4d29-97ff-3b45283bbab13
749817lanreotide 90 MG in 0.3 ML Prefilled SyringePSN2892b4c3-0329-4d29-97ff-3b45283bbab13
7498110.2 ML lanreotide 300 MG/ML Prefilled SyringeSCD2892b4c3-0329-4d29-97ff-3b45283bbab13
7498170.3 ML lanreotide 300 MG/ML Prefilled SyringeSCD2892b4c3-0329-4d29-97ff-3b45283bbab13
7498140.5 ML lanreotide 240 MG/ML Prefilled SyringeSCD2892b4c3-0329-4d29-97ff-3b45283bbab13
7498140.5 ML lanreotide 240 MG/ML (as lanreotide acetate) Prefilled SyringeSY2892b4c3-0329-4d29-97ff-3b45283bbab13
749814lanreotide 120 MG per 0.5 ML Prefilled SyringeSY2892b4c3-0329-4d29-97ff-3b45283bbab13
749811lanreotide 60 MG per 0.2 ML (as lanreotide acetate) Prefilled SyringeSY2892b4c3-0329-4d29-97ff-3b45283bbab13
749817lanreotide 90 MG per 0.3 ML (as lanreotide acetate) Prefilled SyringeSY2892b4c3-0329-4d29-97ff-3b45283bbab13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69097-906-67690970906671 POUCH in 1 CARTON (69097-906-67) / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE1 pouch2025-05-30NoNoHistorical