NDC 0781-3001

Omnitrope

Somatropin

Omnitrope is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Somatropin.

• Product ID: 0781-3001_0684f2d9-9697-4134-aa35-ec180bdd790c
• NDC: 0781-3001
• Product Type: Human Prescription Drug
• Proprietary Name: Omnitrope
• Generic Name: Somatropin
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2006-05-30
• Marketing Category: NDA / NDA
• Application Number: NDA021426
• Labeler Name: Sandoz Inc
• Substance Name: SOMATROPIN
• Active Ingredient Strength: 5 mg/1.5mL
• Pharm Classes: Recombinant Human Growth Hormone [EPC],Human Growth Hormone [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0781-3001-07

1 CARTRIDGE in 1 CARTON (0781-3001-07) > 1.5 mL in 1 CARTRIDGE

• Marketing Start Date: 2006-05-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0781-3001-07 [00781300107]

Omnitrope INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA021426
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2006-05-30

NDC 0781-3001-26 [00781300126]

Omnitrope INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA021426
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2006-05-30

NDC 0781-3001-44 [00781300144]

Omnitrope INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA021426
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2006-05-30
• Marketing End Date: 2010-05-25

Drug Details

Active Ingredients

Ingredient	Strength
SOMATROPIN	5 mg/1.5mL

OpenFDA Data

• SPL SET ID: 58d84ffa-4056-4e36-ad67-7bd4aef444a5
• Manufacturer:
  • Sandoz Inc
• UNII:
  • NQX9KB6PCL
• RxNorm Concept Unique ID - RxCUI:
  • 854302
  • 864110
  • 241975
  • 645884
  • 1736267
  • 1736337

Pharmacological Class

• Recombinant Human Growth Hormone [EPC]
• Human Growth Hormone [CS]

NDC Crossover Matching brand name "Omnitrope" or generic name "Somatropin"

NDC	Brand Name	Generic Name
0781-3004	Omnitrope	Omnitrope
0781-3001	Omnitrope	Omnitrope
0781-4004	Omnitrope	Omnitrope
0013-2626	GENOTROPIN	somatropin
0013-2646	GENOTROPIN	somatropin
0013-2649	GENOTROPIN	somatropin
0013-2650	GENOTROPIN	somatropin
0013-2651	GENOTROPIN	somatropin
0002-7335	HUMATROPE	Somatropin
0002-8147	HUMATROPE	Somatropin
0002-8148	HUMATROPE	Somatropin
0002-8149	HUMATROPE	Somatropin