Prescription drug · ANDA
Doxercalciferol NDC 55150-357
Doxercalciferol 2 ug/mL · Injection, Solution · Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-357-50 | 55150035750 | 50 CARTON in 1 CARTON (55150-357-50) / 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-357-01) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 24, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Doxercalciferol
- Generic name (nonproprietary)
- doxercalciferol
- Active ingredients
- Doxercalciferol — 2 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Eugia US LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213717
- Marketing start
- Listing expires
- Other FDA classes
- Ergocalciferols (Chemical structure)
- Identifiers
- Product ID 55150-357_211361e9-87ad-476a-af8f-8b887c3b6c4eSPL ID 211361e9-87ad-476a-af8f-8b887c3b6c4eSPL set ID 3376536b-043d-478a-b129-7ce11ec94e3eRxCUI 282609, 1790208, 1790219UNII 3DIZ9LF5Y9UPC 0355150358014, 0355150357017
- Pharmacologic class
- Vitamin D2 Analog
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
N455150035750followed by a unit qualifier and the quantityPackage 55150-0357-50. 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)
Doxercalciferol injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on dialysis. Doxercalciferol is a synthetic vitamin D 2 analog: Doxercalciferol injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on dialysis. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213717
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 |
|---|---|---|---|---|
| Doxercalciferol | Doxercalciferol 4 ug/2mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-358 |
| Doxercalciferol | Doxercalciferol 4 ug/2mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-359 |