NDC codes

FDA NDC Directory
Product NDC (as listed)42291-939Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42291-0939Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
42291-939-124229109391242291093912120 TABLET, FILM COATED in 1 BOTTLE (42291-939-12)Marketed from Apr 23, 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
Active ingredients
Pazopanib hydrochloride — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
AvKARENDC labeler code 42291
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217517
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 42291-939_48c0ee87-f725-1a71-e063-6394a90a72d1SPL ID 48c0ee87-f725-1a71-e063-6394a90a72d1SPL set ID 16c5df52-0031-034d-e063-6294a90a1717RxCUI 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

N442291093912 followed by a unit qualifier and the quantity

Package 42291-0939-12. 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 tablets are 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 Us…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-939

What is NDC 42291-939?
42291-939 is the product NDC for Pazopanib, Pazopanib hydrochloride 200 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pazopanib.
What is the active ingredient?
Pazopanib hydrochloride.
Who is the labeler?
AvKARE, NDC labeler code 42291. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Pazopanib NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
pazopanibpazopanib hydrochloridePazopanib hydrochloride 400 mg/1Tablet, Film coatedOralTorrent Pharmaceuticals Limited13668-73513668-0735-3013668-0735-6013668-0735-90
PazopanibPazopanib hydrochloride 200 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-58259651-0582-0859651-0582-3059651-0582-90
pazopanibpazopanib hydrochloridePazopanib hydrochloride 200 mg/1Tablet, Film coatedOralNovugen Pharma (USA) LLC.82293-02282293-0022-10
PazopanibPazopanib hydrochloride 200 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-418400480-4184-89
PazopanibPazopanib hydrochloride 200 mg/1Tablet, Film coatedOralSUN PHARMACEUTICAL INDUSTRIES, INC.63304-11663304-0116-1363304-0116-30
PazopanibPazopanib 200 mg/1TabletOralGolden State Medical Supply, Inc.51407-87251407-0872-12
PazopanibPazopanib 200 mg/1TabletOralApotex Corp.60505-477960505-4779-0560505-4779-07

Other NDCs under ANDA 217517

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 217517
ProductStrengthForm · routeLabelerProduct NDC
PazopanibPazopanib hydrochloride 200 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-4184

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