NDC 0169-7704
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 | 0169-7704_4126dc90-ae9b-4ed4-91ba-afdd8bc24036 |
| NDC | 0169-7704 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Norditropin |
| Generic Name | Somatropin |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 2005-01-03 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021148 |
| Labeler Name | Novo Nordisk |
| 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 | 2020-12-31 |
Packaging
NDC 0169-7704-21
1 SYRINGE, PLASTIC in 1 CARTON (0169-7704-21) > 1.5 mL in 1 SYRINGE, PLASTIC
| Marketing Start Date | 2010-03-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0169-7704-92 [00169770492]
Norditropin INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021148 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-03-01 |
NDC 0169-7704-91 [00169770491]
Norditropin INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021148 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2005-01-03 |
| Marketing End Date | 2012-11-14 |
NDC 0169-7704-11 [00169770411]
Norditropin INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021148 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2005-01-03 |
| Marketing End Date | 2012-11-14 |
NDC 0169-7704-21 [00169770421]
Norditropin INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021148 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-03-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SOMATROPIN | 5 mg/1.5mL |
OpenFDA Data
| SPL SET ID: | 1058e17c-9261-459c-a3e6-fae38d196c14 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
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 |
Trademark Results [Norditropin]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NORDITROPIN 73752012 1745458 Live/Registered |
NORDISK GENTOFTE A/S 1988-09-15 |
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