NDC codes

FDA NDC Directory
Product NDC (as listed)63304-116Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63304-0116Add 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
63304-116-136330401161363304011613120 TABLET, FILM COATED in 1 BOTTLE (63304-116-13)Marketed from Oct 20, 2023
63304-116-30633040116306330401163030 TABLET, FILM COATED in 1 BOTTLE (63304-116-30)Marketed from Oct 20, 2023

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
SUN PHARMACEUTICAL INDUSTRIES, INC.NDC labeler code 63304
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215837
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 63304-116_522bc5e6-38ab-65fd-e063-6394a90a97d6SPL ID 522bc5e6-38ab-65fd-e063-6394a90a97d6SPL set ID d3e8dd09-d7d2-43da-8f63-bdf0ea0fcdf5RxCUI 867502UNII 33Y9ANM545UPC 0363304116137
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

N463304011613 followed by a unit qualifier and the quantity

Package 63304-0116-13. 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 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 : Th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63304-116

What is NDC 63304-116?
63304-116 is the product NDC for Pazopanib, Pazopanib hydrochloride 200 mg/1 tablet, film coated, listed with the FDA by SUN PHARMACEUTICAL INDUSTRIES, INC.. It has 2 package NDCs, 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?
SUN PHARMACEUTICAL INDUSTRIES, INC., NDC labeler code 63304. 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 coatedOralAvKARE42291-93942291-0939-12
PazopanibPazopanib hydrochloride 200 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-418400480-4184-89
PazopanibPazopanib 200 mg/1TabletOralGolden State Medical Supply, Inc.51407-87251407-0872-12
PazopanibPazopanib 200 mg/1TabletOralApotex Corp.60505-477960505-4779-0560505-4779-07

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