NDC 0078-0181

Sandostatin

Octreotide Acetate

Sandostatin is a Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Octreotide Acetate.

• Product ID: 0078-0181_5b689d42-d065-4d77-be63-0d30a07deb89
• NDC: 0078-0181
• Product Type: Human Prescription Drug
• Proprietary Name: Sandostatin
• Generic Name: Octreotide Acetate
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 1988-10-21
• Marketing Category: NDA / NDA
• Application Number: NDA019667
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: OCTREOTIDE ACETATE
• Active Ingredient Strength: 100 ug/mL
• Pharm Classes: Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0078-0181-01

10 AMPULE in 1 PACKAGE (0078-0181-01) > 1 mL in 1 AMPULE (0078-0181-61)

• Marketing Start Date: 1988-10-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0181-01 [00078018101]

Sandostatin INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA019667
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1988-10-21

NDC 0078-0181-61 [00078018161]

Sandostatin INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA019667
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-08-13

Drug Details

Active Ingredients

Ingredient	Strength
OCTREOTIDE ACETATE	100 ug/mL

OpenFDA Data

• SPL SET ID: 4e2c9856-1836-49f0-9472-4dbeeb408f39
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 75R0U2568I
• RxNorm Concept Unique ID - RxCUI:
  • 312071
  • 312070
  • 207201
  • 207200
  • 312068
  • 312069
  • 207199
  • 207198
  • 207194
  • 314152

Pharmacological Class

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

NDC Crossover Matching brand name "Sandostatin" or generic name "Octreotide Acetate"

NDC	Brand Name	Generic Name
0078-0180	Sandostatin	octreotide acetate
0078-0181	Sandostatin	octreotide acetate
0078-0182	Sandostatin	octreotide acetate
0078-0183	Sandostatin	octreotide acetate
0078-0184	Sandostatin	octreotide acetate
0641-6174	Octreotide Acetate	Octreotide Acetate
0641-6175	Octreotide Acetate	Octreotide Acetate
0078-0647	Sandostatin LAR Depot	octreotide acetate
0078-0648	Sandostatin LAR Depot	octreotide acetate
0078-0811	Sandostatin LAR Depot	octreotide acetate
0078-0818	Sandostatin LAR Depot	octreotide acetate
0078-0825	Sandostatin LAR Depot	octreotide acetate