Lanreotide Acetate

Product NDC
69097-870
11-digit product format
690970870
Labeler code
69097
Product ID
69097-870_fd205110-15eb-4707-82b2-185e5bbf616b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lanreotide acetate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Cipla USA Inc.
Application
NDA215395
Marketing category
NDA
Marketing start
2021-12-24
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-870-67Lanreotide Acetate1 in 1 CARTONINJECTION17
69097-870-67Lanreotide Acetate0.5 mL in 1 SYRINGEINJECTION0.57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-870-67ML - Milliliter69097-870847d9077-47fa-4350-bca1-97b3ef70370712022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-870LANREOTIDE ACETATE INJECTION [CIPLA USA INC.]7Current NDC, Legacy NDC, 2 package rows20240925_11da176a-99bc-4ada-8b3f-6bd2b37a6313.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749814lanreotide 120 MG in 0.5 ML Prefilled SyringePSN11da176a-99bc-4ada-8b3f-6bd2b37a63137
749811lanreotide 60 MG in 0.2 ML Prefilled SyringePSN11da176a-99bc-4ada-8b3f-6bd2b37a63137
749817lanreotide 90 MG in 0.3 ML Prefilled SyringePSN11da176a-99bc-4ada-8b3f-6bd2b37a63137
7498110.2 ML lanreotide 300 MG/ML Prefilled SyringeSCD11da176a-99bc-4ada-8b3f-6bd2b37a63137
7498170.3 ML lanreotide 300 MG/ML Prefilled SyringeSCD11da176a-99bc-4ada-8b3f-6bd2b37a63137
7498140.5 ML lanreotide 240 MG/ML Prefilled SyringeSCD11da176a-99bc-4ada-8b3f-6bd2b37a63137
7498140.5 ML lanreotide 240 MG/ML (as lanreotide acetate) Prefilled SyringeSY11da176a-99bc-4ada-8b3f-6bd2b37a63137
749814lanreotide 120 MG per 0.5 ML Prefilled SyringeSY11da176a-99bc-4ada-8b3f-6bd2b37a63137
749811lanreotide 60 MG per 0.2 ML (as lanreotide acetate) Prefilled SyringeSY11da176a-99bc-4ada-8b3f-6bd2b37a63137
749817lanreotide 90 MG per 0.3 ML (as lanreotide acetate) Prefilled SyringeSY11da176a-99bc-4ada-8b3f-6bd2b37a63137

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-870-67690970870671 SYRINGE in 1 CARTON (69097-870-67) / .5 mL in 1 SYRINGE1 syringe2021-12-240000-00-00NoNoCurrent