NDC 54868-6146
Norditropin 5 mg per 1.5 mL injection, solution
On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from Novo Nordisk's NDC 0169-7704.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Novo Nordisk A/S - Hax | Gentofte, Denmark | Makes it and makes the active ingredient | Problems found, fixed voluntarilyJun 1, 2023 · 6 inspections |
| Novo Nordisk A/S - Kv | Vaerlose, Denmark | Makes it | Problems found, fixed voluntarilyMay 2, 2024 · 2 inspections |
Recalls
- Apr 27, 2016 · Class II · Novo Nordisk Inc
Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
Lots: Lot Number FC70222
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Somatropin: every company that makes it
- Form
- injection, solution
- Strength
- 5 mg per 1.5 mL
- Approval
- NDA NDA021148
- On the market since
- Aug 10, 2010
- Package NDCs
54868-6146-0- Official label
- DailyMed (National Library of Medicine), updated Mar 2, 2010
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