Prescription drug · NDA
Paricalcitol NDC 16729-311
Paricalcitol 5 ug/mL · Injection, Solution · Intravenous · Accord Healthcare, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-311-08 | 16729031108 | 25 VIAL, SINGLE-DOSE in 1 CARTON (16729-311-08) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 24, 2016 | |
| 16729-311-30 | 16729031130 | 1 VIAL, MULTI-DOSE in 1 CARTON (16729-311-30) / 2 mL in 1 VIAL, MULTI-DOSEMarketed from Mar 24, 2016 | |
| 16729-311-63 | 16729031163 | 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-311-63) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 24, 2016 | |
| 16729-311-93 | 16729031193 | 25 VIAL, MULTI-DOSE in 1 CARTON (16729-311-93) / 2 mL in 1 VIAL, MULTI-DOSEMarketed from Mar 24, 2016 |
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)
- Paricalcitol
- Generic name (nonproprietary)
- paricalcitol
- Active ingredients
- Paricalcitol — 5 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Accord Healthcare, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207174
- Marketing start
- Listing expires
- Other FDA classes
- Ergocalciferols (Chemical structure)
- Identifiers
- Product ID 16729-311_1e7e9c4e-79dd-a776-e063-6394a90a43a1SPL ID 1e7e9c4e-79dd-a776-e063-6394a90a43a1SPL set ID 2b7c7587-2042-0d9c-e054-00144ff88e88RxCUI 200321, 1736919, 1736931UNII 6702D36OG5UPC 0316729310635, 0316729311304, 0316729311632, 0316729311083
- Pharmacologic class
- Vitamin D Analog; 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
N416729031108followed by a unit qualifier and the quantityPackage 16729-0311-08. 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)
Paricalcitol Injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis. Paricalcitol Injection is a vitamin D analog indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease on dialysis.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 207174
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 |
|---|---|---|---|---|
| Paricalcitol | Paricalcitol 2 ug/mL | Injection, SolutionIntravenous | Accord Healthcare, Inc. | 16729-310 |