NDC 0169-7703

Norditropin

Somatropin

Norditropin is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Novo Nordisk. The primary component is Somatropin.

• Product ID: 0169-7703_4126dc90-ae9b-4ed4-91ba-afdd8bc24036
• NDC: 0169-7703
• Product Type: Human Prescription Drug
• Proprietary Name: Norditropin
• Generic Name: Somatropin
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2009-03-30
• Marketing Category: NDA / NDA
• Application Number: NDA021148
• Labeler Name: Novo Nordisk
• Substance Name: SOMATROPIN
• Active Ingredient Strength: 30 mg/3mL
• Pharm Classes: Recombinant Human Growth Hormone [EPC],Human Growth Hormone [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0169-7703-21

1 SYRINGE in 1 CARTON (0169-7703-21) > 3 mL in 1 SYRINGE

• Marketing Start Date: 2015-01-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0169-7703-21 [00169770321]

Norditropin INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021148
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-01-23

NDC 0169-7703-92 [00169770392]

Norditropin INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021148
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-01-23

NDC 0169-7703-91 [00169770391]

Norditropin INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021148
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-01-23
• Marketing End Date: 2015-07-06

NDC 0169-7703-11 [00169770311]

Norditropin INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021148
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-01-23
• Marketing End Date: 2015-07-06

Drug Details

Active Ingredients

Ingredient	Strength
SOMATROPIN	30 mg/3mL

OpenFDA Data

• SPL SET ID: 1058e17c-9261-459c-a3e6-fae38d196c14
• Manufacturer:
  • Novo Nordisk
• UNII:
  • NQX9KB6PCL
• RxNorm Concept Unique ID - RxCUI:
  • 849850
  • 849851
  • 847348
  • 1736329
  • 1736262
  • 847243
  • 847245
  • 847247

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0169-7708	Norditropin	Norditropin
0169-7704	Norditropin	Norditropin
0169-7705	Norditropin	Norditropin
0169-7703	Norditropin	Norditropin
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