Prescription drug · BLA
Omnitrope (Somatropin) NDC 0781-3001
Somatropin 5 mg/1.5mL · Injection, Solution · Subcutaneous · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-3001-07 | 00781300107 | 1 CARTRIDGE in 1 CARTON (0781-3001-07) / 1.5 mL in 1 CARTRIDGEMarketed from May 30, 2006 | |
| 0781-3001-26 | 00781300126 | 5 CARTRIDGE in 1 CARTON (0781-3001-26) / 1.5 mL in 1 CARTRIDGEMarketed from May 30, 2006 |
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)
- Omnitrope
- Generic name (nonproprietary)
- somatropin
- Active ingredients
- Somatropin — 5 mg/1.5mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 021426
- Marketing start
- Listing expires
- Other FDA classes
- Human Growth Hormone (Chemical structure)
- Identifiers
- Product ID 0781-3001_22eba20c-aa55-440d-846e-a1235440fecbSPL ID 22eba20c-aa55-440d-846e-a1235440fecbSPL set ID 58d84ffa-4056-4e36-ad67-7bd4aef444a5RxCUI 241975, 645884, 854302, 864110, 1736267, 1736337UNII NQX9KB6PCL
- 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
N400781300107followed by a unit qualifier and the quantityPackage 00781-3001-07. 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)
OMNITROPE is a recombinant human growth hormone indicated for: • Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature ( 1.1 ) • Adult: Treatment of adults with either adult onset or childhood onset GHD ( 1.2 ) 1.1 Pediatric Patients OMNITROPE is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH). OMNITROPE is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi Syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing …
Excerpt only. Read the full label for complete information.
About NDC 0781-3001
- What is NDC 0781-3001?
- 0781-3001 is the product NDC for Omnitrope (somatropin), Somatropin 5 mg/1.5mL injection, solution, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omnitrope (Somatropin).
- What is the active ingredient?
- Somatropin.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Omnitrope?
- 2 other product NDCs are listed under this name. See all Omnitrope NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Omnitrope products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Omnitropesomatropin | — | Kit | Sandoz Inc | 0781-4004 | 00781-4004-36 |
| Omnitropesomatropin | Somatropin 10 mg/1.5mL | Injection, SolutionSubcutaneous | Sandoz Inc | 0781-3004 | 00781-3004-0700781-3004-26 |
Other NDCs under BLA 021426
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 |
|---|---|---|---|---|
| Omnitropesomatropin | — | Kit | Sandoz Inc | 0781-4004 |
| Omnitropesomatropin | Somatropin 10 mg/1.5mL | Injection, SolutionSubcutaneous | Sandoz Inc | 0781-3004 |