Prescription drug · ANDA
Paricalcitol NDC 49483-689
Paricalcitol 4 ug/1 · Capsule, Liquid filled · Oral · TIME CAP LABORATORIES, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-689-03 | 49483068903 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-689-03)Marketed from Jan 3, 2017 |
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 — 4 ug/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204948
- Marketing start
- Listing expires
- Other FDA classes
- Ergocalciferols (Chemical structure)
- Identifiers
- Product ID 49483-689_eed565d0-059d-eef6-e053-2a95a90ac962SPL ID eed565d0-059d-eef6-e053-2a95a90ac962SPL set ID f593b575-7537-4531-87fc-c1b0814fd018RxCUI 577315, 577317, 577324UNII 6702D36OG5UPC 0349483687033, 0349483688030, 0349483689037
- 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 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
N449483068903followed by a unit qualifier and the quantityPackage 49483-0689-03. 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)
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 that pediatric information. 1.2 Chronic Kidney Disease Stage 5 Paricalcitol Capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD)…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204948
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 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | 49483-687 |
| Paricalcitol | Paricalcitol 2 ug/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | 49483-688 |
| Paricalcitol | Paricalcitol 2 ug/1 | Capsule, Liquid filledOral | MARKSANS PHARMA LIMITED | 25000-014 |
| Paricalcitol | Paricalcitol 1 ug/1 | Capsule, Liquid filledOral | MARKSANS PHARMA LIMITED | 25000-012 |
| Paricalcitol | Paricalcitol 4 ug/1 | Capsule, Liquid filledOral | MARKSANS PHARMA LIMITED | 25000-017 |