Prescription drug · BLA
Ngenla (Somatrogon-ghla) NDC 0069-0505
Somatrogon 24 mg/1.2mL · Injection, Solution · Subcutaneous · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-0505-02 | 00069050502 | 1 CARTRIDGE in 1 CARTON (0069-0505-02) / 1.2 mL in 1 CARTRIDGE (0069-0505-01)Marketed from Jul 31, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ngenla
- Generic name (nonproprietary)
- somatrogon-ghla
- Active ingredients
- Somatrogon — 24 mg/1.2mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761184
- Marketing start
- Listing expires
- Other FDA classes
- 11-beta Hydroxysteroid Dehydrogenase Type 1 Inhibitors (Mechanism)Human Growth Hormone (Chemical structure)
- Identifiers
- Product ID 0069-0505_7720dd2d-dc7e-4f9c-b7e5-7581d44ee9b5SPL ID 7720dd2d-dc7e-4f9c-b7e5-7581d44ee9b5SPL set ID 06dce529-b741-4a1b-8842-3ad77be6e308RxCUI 2644517, 2644523, 2644526, 2644529UNII 6D848RA61B
- Pharmacologic class
- Recombinant Human Growth Hormone
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400069050502followed by a unit qualifier and the quantityPackage 00069-0505-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone. NGENLA is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 0069-0505
- What is NDC 0069-0505?
- 0069-0505 is the product NDC for Ngenla (somatrogon-ghla), Somatrogon 24 mg/1.2mL injection, solution, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ngenla (Somatrogon-ghla).
- What is the active ingredient?
- Somatrogon.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ngenla?
- 1 other product NDC are listed under this name. See all Ngenla NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ngenla products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ngenlasomatrogon-ghla | Somatrogon 60 mg/1.2mL | Injection, SolutionSubcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-0520 | 00069-0520-02 |
Other NDCs under BLA 761184
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ngenlasomatrogon-ghla | Somatrogon 60 mg/1.2mL | Injection, SolutionSubcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-0520 |