Prescription drug · ANDA
Paricalcitol NDC 49483-688
Paricalcitol 2 ug/1 · Capsule, Liquid filled · Oral · TIME CAP LABORATORIES, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-688-03 | 49483068803 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-688-03)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 — 2 ug/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INCNDC labeler code 49483
- 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 49483-688_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
N449483068803followed by a unit qualifier and the quantityPackage 49483-0688-03. 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 49483-688
- What is NDC 49483-688?
- 49483-688 is the product NDC for Paricalcitol, Paricalcitol 2 ug/1 capsule, liquid filled, listed with the FDA by TIME CAP LABORATORIES, INC. It has 1 package NDC, 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?
- TIME CAP LABORATORIES, INC, NDC labeler code 49483. 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 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 | Eugia US LLC | 55150-212 | 55150-0212-01 |
| Paricalcitol | Paricalcitol 10 ug/2mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1035 | 70121-1035-0570121-1035-07 |
| 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 | 70121-1036 | 70121-1036-0570121-1036-07 |
| Paricalcitol | Paricalcitol 1 ug/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | 49483-687 | 49483-0687-03 |
| Paricalcitol | Paricalcitol 4 ug/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | 49483-689 | 49483-0689-03 |
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 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 |
| Paricalcitol | Paricalcitol 1 ug/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | 49483-687 |
| Paricalcitol | Paricalcitol 4 ug/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | 49483-689 |