Prescription drug · ANDA
Paricalcitol NDC 69452-145
Paricalcitol 1 ug/1 · Capsule · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-145-13 | 69452014513 | 30 CAPSULE in 1 BOTTLE, PLASTIC (69452-145-13)Marketed from Aug 16, 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 — 1 ug/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bionpharma Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202539
- Marketing start
- Listing expires
- Other FDA classes
- Ergocalciferols (Chemical structure)
- Identifiers
- Product ID 69452-145_0d856fce-7c7d-18e7-e063-6394a90ac945SPL ID 0d856fce-7c7d-18e7-e063-6394a90ac945SPL set ID 755476e5-62a2-4f01-92a3-307e192ad42cRxCUI 577315, 577317, 577324UNII 6702D36OG5UPC 0369452147139, 0369452145135
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469452014513followed by a unit qualifier and the quantityPackage 69452-0145-13. 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 is a vitamin D analog indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with: Chronic kidney disease (CKD) Stages 3 and 4 ( 1.1 ). CKD Stage 5 in patients on hemodialysis or peritoneal dialysis ( 1.2 ). 1.1 Chronic Kidney Disease Stages 3 and 4 Paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4. Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202539
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 1 ug/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1915 |
| Paricalcitol | Paricalcitol 2 ug/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1916 |
| Paricalcitol | Paricalcitol 2 ug/1 | CapsuleOral | Bionpharma Inc. | 69452-146 |
| Paricalcitol | Paricalcitol 4 ug/1 | CapsuleOral | Bionpharma Inc. | 69452-147 |
| Paricalcitol | Paricalcitol 2 ug/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2453 |
| Paricalcitol | Paricalcitol 1 ug/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2452 |