What is NDC 63850-0059?

63850-0059 is the product NDC for Everolimus, Everolimus 5 mg/1 tablet, listed with the FDA by Natco Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Natco Pharma Limited, NDC labeler code 63850. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Everolimus?

65 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Everolimus NDC 63850-0059 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63850-0059Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63850-0059Add 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 NDC	11-digit (billing)	Package	Copy
63850-0059-1	6385000590163850005901	4 BLISTER PACK in 1 CARTON (63850-0059-1) / 7 TABLET in 1 BLISTER PACKMarketed from Mar 5, 2021
63850-0059-4	6385000590463850005904	30 TABLET in 1 BOTTLE (63850-0059-4)Marketed from May 26, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Everolimus
Generic name (nonproprietary): everolimus
Active ingredients: Everolimus — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Natco Pharma LimitedNDC labeler code 63850
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205426
Marketing start: Mar 5, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
Identifiers: Product ID 63850-0059_6df3819e-2d45-4030-a4af-6caeccb8a471SPL ID 6df3819e-2d45-4030-a4af-6caeccb8a471SPL set ID e3dbbc24-7e55-4069-a305-e2cded2db641RxCUI 845507, 845515, 998189, 1119400UNII 9HW64Q8G6GUPC 0363850006128, 0363850005817, 0363850006111, 0363850005923, 0363850005824, 0363850005916, 0363850006012
Pharmacologic class: Kinase Inhibitor; mTOR Inhibitor Immunosuppressant

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

N463850005901 followed by a unit qualifier and the quantity

Package 63850-0059-01. 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 Jun 8, 2023.

Indications (excerpt from the label)

Everolimus tablets are a kinase inhibitor indicated for the treatment of: Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. ( 1.3 ) Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. ( 1.4 ) Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. ( 1.5 ) 1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer Everolimus tablets are indicated for the treatment of postmenopausal women wi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63850-0059

What is NDC 63850-0059?: 63850-0059 is the product NDC for Everolimus, Everolimus 5 mg/1 tablet, listed with the FDA by Natco Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Everolimus.
What is the active ingredient?: Everolimus.
Who is the labeler?: Natco Pharma Limited, NDC labeler code 63850. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Everolimus?: 65 other product NDCs are listed under this name. See all Everolimus 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 Everolimus NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Everolimus	Everolimus .25 mg/1	TabletOral	i3 Pharmaceuticals, LLC	72319-003	72319-0003-0272319-0003-60
Everolimus	Everolimus .5 mg/1	TabletOral	i3 Pharmaceuticals, LLC	72319-015	72319-0015-0272319-0015-60
Everolimus	Everolimus .75 mg/1	TabletOral	i3 Pharmaceuticals, LLC	72319-016	72319-0016-0272319-0016-60
Everolimus	Everolimus 1 mg/1	TabletOral	i3 Pharmaceuticals, LLC	72319-017	72319-0017-0272319-0017-60
everolimus	Everolimus 7.5 mg/1	TabletOral	Novugen Pharma (USA) LLC.	82293-032	82293-0032-1082293-0032-2182293-0032-31
everolimus	Everolimus 2.5 mg/1	TabletOral	Novugen Pharma (USA) LLC.	82293-030	82293-0030-1082293-0030-2182293-0030-31
everolimus	Everolimus 5 mg/1	TabletOral	Novugen Pharma (USA) LLC.	82293-031	82293-0031-1082293-0031-2182293-0031-31
everolimus	Everolimus 10 mg/1	TabletOral	Novugen Pharma (USA) LLC.	82293-033	82293-0033-1082293-0033-2182293-0033-31
everolimus	Everolimus .75 mg/1	TabletOral	Aurobindo Pharma Limited	59651-933	59651-0933-60
everolimus	Everolimus .25 mg/1	TabletOral	Aurobindo Pharma Limited	59651-931	59651-0931-60

All 66 Everolimus NDCs

Other NDCs under ANDA 205426

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

FDA NDC Directory listings under ANDA 205426
Product	Strength	Form · route	Labeler	Product NDC
Everolimus	Everolimus 2.5 mg/1	TabletOral	Natco Pharma Limited	63850-0058
Everolimus	Everolimus 7.5 mg/1	TabletOral	Natco Pharma Limited	63850-0060
Everolimus	Everolimus 10 mg/1	TabletOral	Natco Pharma Limited	63850-0061
Everolimus	Everolimus 2.5 mg/1	TabletOral	Breckenridge Pharmaceutical, Inc.	51991-821
Everolimus	Everolimus 10 mg/1	TabletOral	Breckenridge Pharmaceutical, Inc.	51991-824
Everolimus	Everolimus 5 mg/1	TabletOral	Breckenridge Pharmaceutical, Inc.	51991-822
Everolimus	Everolimus 7.5 mg/1	TabletOral	Breckenridge Pharmaceutical, Inc.	51991-823
Yulithiraeverolimus	Everolimus 5 mg/1	TabletOral	CivicaScript, LLC	82249-611
Yulithiraeverolimus	Everolimus 2.5 mg/1	TabletOral	CivicaScript, LLC	82249-610
Yulithiraeverolimus	Everolimus 7.5 mg/1	TabletOral	CivicaScript, LLC	82249-612
Yulithiraeverolimus	Everolimus 10 mg/1	TabletOral	CivicaScript, LLC	82249-613