Prescription drug · ANDA
pazopanib (Pazopanib hydrochloride) NDC 82293-022
Pazopanib hydrochloride 200 mg/1 · Tablet, Film coated · Oral · Novugen Pharma (USA) LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82293-022-10 | 8229300221082293002210 | 120 TABLET, FILM COATED in 1 BOTTLE (82293-022-10)Marketed from Apr 24, 2024 |
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)
- pazopanib
- Generic name (nonproprietary)
- pazopanib hydrochloride
- Active ingredients
- Pazopanib hydrochloride — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Novugen Pharma (USA) LLC.NDC labeler code 82293
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218231
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 82293-022_2007980f-ffca-6d8f-e063-6294a90ae3ffSPL ID 2007980f-ffca-6d8f-e063-6294a90ae3ffSPL set ID 25305d33-caa0-4577-8b7b-06e430c34c39RxCUI 867502UNII 33Y9ANM545
- Pharmacologic class
- Kinase Inhibitor
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
N482293002210followed by a unit qualifier and the quantityPackage 82293-0022-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Pazopanib is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). ( 1.1 ) advanced soft tissue sarcoma (STS) who have received prior chemotherapy. ( 1.2 ) Limitations of Use : The efficacy of pazopanib tablets for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. 1.1 Renal Cell Carcinoma Pazopanib tablets are indicated for the treatment of adults with advanced renal cell carcinoma (RCC). 1.2 Soft Tissue Sarcoma Pazopanib tablets are indicated for the treatment of adults with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. Limitations of Use : The e…
Excerpt only. Read the full label for complete information.
About NDC 82293-022
- What is NDC 82293-022?
- 82293-022 is the product NDC for pazopanib (pazopanib hydrochloride), Pazopanib hydrochloride 200 mg/1 tablet, film coated, listed with the FDA by Novugen Pharma (USA) LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- pazopanib (Pazopanib hydrochloride).
- What is the active ingredient?
- Pazopanib hydrochloride.
- Who is the labeler?
- Novugen Pharma (USA) LLC., NDC labeler code 82293. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for pazopanib?
- 7 other product NDCs are listed under this name. See all pazopanib NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other pazopanib products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| pazopanibpazopanib hydrochloride | Pazopanib hydrochloride 400 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-735 | 13668-0735-3013668-0735-6013668-0735-90 |
| Pazopanib | Pazopanib hydrochloride 200 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-582 | 59651-0582-0859651-0582-3059651-0582-90 |
| Pazopanib | Pazopanib hydrochloride 200 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-939 | 42291-0939-12 |
| Pazopanib | Pazopanib hydrochloride 200 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-4184 | 00480-4184-89 |
| Pazopanib | Pazopanib hydrochloride 200 mg/1 | Tablet, Film coatedOral | SUN PHARMACEUTICAL INDUSTRIES, INC. | 63304-116 | 63304-0116-1363304-0116-30 |
| Pazopanib | Pazopanib 200 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-872 | 51407-0872-12 |
| Pazopanib | Pazopanib 200 mg/1 | TabletOral | Apotex Corp. | 60505-4779 | 60505-4779-0560505-4779-07 |