Norditropin
- Product NDC
- 0169-7708
- 11-digit product format
- 001697708
- Labeler code
- 0169
- Product ID
- 0169-7708_b67c2419-4feb-4ce1-b97e-88760a8e1aee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- somatropin
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Novo Nordisk
- Application
- BLA021148
- Marketing category
- BLA
- Marketing start
- 2005-01-03
- Substance
- SOMATROPIN
- Active strength
- 15 mg/1.5mL
- Pharmacologic classes
- Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Norditropin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SOMATROPIN | 15 mg/1.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NQX9KB6PCL |
| Rxcui | 847243, 847245, 847247, 847348, 849850, 849851, 1736262, 1736329 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0169-7708-21 | Norditropin | 1.5 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 1.5 | | 30 |
| 0169-7708-21 | Norditropin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 30 |
| 0169-7708-92 | Norditropin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 30 |
| 0169-7708-92 | Norditropin | 1.5 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 1.5 | | 30 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SOMATROPIN | ACTIVE INGREDIENT | NQX9KB6PCL | NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| SOMATROPIN | ACTIVE MOIETY | NQX9KB6PCL | NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| HISTIDINE | INACTIVE INGREDIENT | 4QD397987E | NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| PHENOL | INACTIVE INGREDIENT | 339NCG44TV | NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK] | 15 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0169-7708 | NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK] | 28 | Current NDC, Legacy NDC, 4 package rows | 20250216_1058e17c-9261-459c-a3e6-fae38d196c14.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0169-7708-21 | 00169770821 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-7708-21) / 1.5 mL in 1 SYRINGE, PLASTIC | 2010-03-01 | 0000-00-00 | No | No | Current |
| 0169-7708-92 | 00169770892 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-7708-92) / 1.5 mL in 1 SYRINGE, PLASTIC | 2010-03-01 | 0000-00-00 | No | No | Current |