NDC 15054-1120

SOMATULINE DEPOT

Lanreotide Acetate

SOMATULINE DEPOT is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Ipsen Biopharmaceuticals, Inc.. The primary component is Lanreotide Acetate.

• Product ID: 15054-1120_26b72434-9556-4e3c-971e-00e46b45fd81
• NDC: 15054-1120
• Product Type: Human Prescription Drug
• Proprietary Name: SOMATULINE DEPOT
• Generic Name: Lanreotide Acetate
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2007-11-14
• Marketing Category: NDA / NDA
• Application Number: NDA022074
• Labeler Name: Ipsen Biopharmaceuticals, Inc.
• Substance Name: LANREOTIDE ACETATE
• Active Ingredient Strength: 120 mg/.5mL
• Pharm Classes: Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 15054-1120-3

1 POUCH in 1 CARTON (15054-1120-3) > 1 SYRINGE in 1 POUCH > .5 mL in 1 SYRINGE

• Marketing Start Date: 2007-11-14
• Marketing End Date: 2022-06-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 15054-1120-4 [15054112004]

SOMATULINE DEPOT INJECTION

• Marketing Category: NDA
• Application Number: NDA022074
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-09-01

NDC 15054-1120-3 [15054112003]

SOMATULINE DEPOT INJECTION

• Marketing Category: NDA
• Application Number: NDA022074
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2007-11-14

Drug Details

Active Ingredients

Ingredient	Strength
LANREOTIDE ACETATE	120 mg/.5mL

OpenFDA Data

• SPL SET ID: 6e4a41fd-a753-4362-87ee-8cc56ed3660d
• Manufacturer:
  • Ipsen Biopharmaceuticals, Inc.
• UNII:
  • IEU56G3J9C
• RxNorm Concept Unique ID - RxCUI:
  • 749818
  • 749817
  • 749816
  • 749814
  • 749813
  • 749811

Pharmacological Class

• Somatostatin Analog [EPC]
• Somatostatin Receptor Agonists [MoA]

NDC Crossover Matching brand name "SOMATULINE DEPOT" or generic name "Lanreotide Acetate"

NDC	Brand Name	Generic Name
15054-1060	SOMATULINE DEPOT	lanreotide acetate
15054-1090	SOMATULINE DEPOT	lanreotide acetate
15054-1120	SOMATULINE DEPOT	lanreotide acetate
69097-870	Lanreotide Acetate	lanreotide acetate
69097-880	Lanreotide Acetate	lanreotide acetate
69097-890	Lanreotide Acetate	lanreotide acetate
76282-709	Lanreotide Acetate	lanreotide acetate
76282-710	Lanreotide Acetate	lanreotide acetate
76282-711	Lanreotide Acetate	lanreotide acetate