Ngenla
- Product NDC
- 0069-0520
- 11-digit product format
- 000690520
- Labeler code
- 0069
- Product ID
- 0069-0520_28203f91-b3df-4b23-907a-10c061afbaf1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- somatrogon-ghla
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- BLA761184
- Marketing category
- BLA
- Marketing start
- 2023-07-31
- Substance
- SOMATROGON
- Active strength
- 60 mg/1.2mL
- Pharmacologic classes
- 11-beta Hydroxysteroid Dehydrogenase Type 1 Inhibitors [MoA], Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ngenla
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SOMATROGON | 60 mg/1.2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6D848RA61B |
| Rxcui | 2644517, 2644523, 2644526, 2644529 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0069-0520-01 | Ngenla | 1.2 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1.2 | | 12 |
| 0069-0520-02 | Ngenla | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0069-0520 | NGENLA (SOMATROGON-GHLA) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 8 | Current NDC, 2 package rows | 20250101_06dce529-b741-4a1b-8842-3ad77be6e308.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0069-0520-01 | 00069052001 | 1.2 mL in 1 CARTRIDGE | 1.2 ml | | | | Historical |
| 0069-0520-02 | 00069052002 | 1 CARTRIDGE in 1 CARTON (0069-0520-02) / 1.2 mL in 1 CARTRIDGE (0069-0520-01) | 1 cartridge | 2023-07-31 | No | No | Current |