Prescription drug · ANDA
Paricalcitol NDC 25000-017
Paricalcitol 4 ug/1 · Capsule, Liquid filled · Oral · MARKSANS PHARMA LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25000-017-03 | 25000001703 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-017-03)Marketed from Dec 31, 2016 | |
| 25000-017-49 | 25000001749 | 4 BAG in 1 BOX (25000-017-49) / 7000 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Dec 31, 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 — 4 ug/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- MARKSANS PHARMA LIMITEDNDC labeler code 25000
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204948
- Marketing start
- Listing expires
- Other FDA classes
- Cholecalciferol (Chemical structure)
- Identifiers
- Product ID 25000-017_d2da21f1-d7f6-43c0-b66f-5b7d14774688SPL ID d2da21f1-d7f6-43c0-b66f-5b7d14774688SPL set ID 0fbaff52-f08f-42b7-8e46-c7214112901aRxCUI 577315, 577317, 577324UNII 6702D36OG5
- Pharmacologic class
- Vitamin D3 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
N425000001703followed by a unit qualifier and the quantityPackage 25000-0017-03. 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.
About NDC 25000-017
- What is NDC 25000-017?
- 25000-017 is the product NDC for Paricalcitol, Paricalcitol 4 ug/1 capsule, liquid filled, listed with the FDA by MARKSANS PHARMA LIMITED. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Paricalcitol.
- What is the active ingredient?
- Paricalcitol.
- Who is the labeler?
- MARKSANS PHARMA LIMITED, NDC labeler code 25000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Paricalcitol?
- 34 other product NDCs are listed under this name. See all Paricalcitol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Paricalcitol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Paricalcitol | Paricalcitol 2 ug/mL | InjectionIntravenous | Eugia US LLC | 55150-212 | 55150-0212-01 |
| Paricalcitol | Paricalcitol 5 ug/mL | InjectionIntravenous | Eugia US LLC | 55150-213 | 55150-0213-01 |
| Paricalcitol | Paricalcitol 10 ug/2mL | InjectionIntravenous | Eugia US LLC | 55150-214 | 55150-0214-02 |
| Paricalcitol | Paricalcitol 10 ug/2mL | InjectionIntravenous | Eugia US LLC | 55150-215 | 55150-0215-02 |
| Paricalcitol | Paricalcitol 2 ug/mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1033 | 70121-1033-0570121-1033-07 |
| Paricalcitol | Paricalcitol 5 ug/mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1034 | 70121-1034-0570121-1034-07 |
| Paricalcitol | Paricalcitol 10 ug/2mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1035 | 70121-1035-0570121-1035-07 |
| Paricalcitol | Paricalcitol 10 ug/2mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1036 | 70121-1036-0570121-1036-07 |
| Paricalcitol | Paricalcitol 4 ug/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | 49483-689 | 49483-0689-03 |
| Paricalcitol | Paricalcitol 1 ug/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | 49483-687 | 49483-0687-03 |
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 4 ug/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | 49483-689 |
| Paricalcitol | Paricalcitol 1 ug/1 | Capsule, Liquid filledOral | MARKSANS PHARMA LIMITED | 25000-012 |
| Paricalcitol | Paricalcitol 2 ug/1 | Capsule, Liquid filledOral | MARKSANS PHARMA LIMITED | 25000-014 |