NDC codes

FDA NDC Directory
Product NDC (as listed)60219-2281Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60219-2281Add 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
60219-2281-2602192281024 BLISTER PACK in 1 CARTON (60219-2281-2) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK (60219-2281-1)Marketed from Jan 14, 2025

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, For suspension
Route
Oral
Labeler
Amneal Pharmaceuticals NY LLCNDC labeler code 60219
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218863
Marketing start
Listing expires
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 60219-2281_0e3290d2-c865-446d-935b-290ce331789aSPL ID 0e3290d2-c865-446d-935b-290ce331789aSPL set ID 6f1ae129-c21e-4c25-84c1-a6757d9a7eb2RxCUI 1308428, 1308430, 1308432UNII 9HW64Q8G6G
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

N460219228102 followed by a unit qualifier and the quantity

Package 60219-2281-02. 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)

Everolimus tablets for oral suspension are kinase inhibitor 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 ) Everolimus tablets for oral suspension are a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. ( 1.6 ) 1.5 Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) Everolimus tablets for oral suspension are indicated in adult and pediatric patients aged 1 year and older with TSC …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60219-2281

What is NDC 60219-2281?
60219-2281 is the product NDC for Everolimus, Everolimus 5 mg/1 tablet, for suspension, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, 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?
Amneal Pharmaceuticals NY LLC, NDC labeler code 60219. 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?
68 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
EverolimusEverolimus .25 mg/1TabletOrali3 Pharmaceuticals, LLC72319-00372319-0003-0272319-0003-60
EverolimusEverolimus .5 mg/1TabletOrali3 Pharmaceuticals, LLC72319-01572319-0015-0272319-0015-60
EverolimusEverolimus .75 mg/1TabletOrali3 Pharmaceuticals, LLC72319-01672319-0016-0272319-0016-60
EverolimusEverolimus 1 mg/1TabletOrali3 Pharmaceuticals, LLC72319-01772319-0017-0272319-0017-60
everolimusEverolimus 7.5 mg/1TabletOralNovugen Pharma (USA) LLC.82293-03282293-0032-1082293-0032-2182293-0032-31
everolimusEverolimus 2.5 mg/1TabletOralNovugen Pharma (USA) LLC.82293-03082293-0030-1082293-0030-2182293-0030-31
everolimusEverolimus 5 mg/1TabletOralNovugen Pharma (USA) LLC.82293-03182293-0031-1082293-0031-2182293-0031-31
everolimusEverolimus 10 mg/1TabletOralNovugen Pharma (USA) LLC.82293-03382293-0033-1082293-0033-2182293-0033-31
everolimusEverolimus .25 mg/1TabletOralAurobindo Pharma Limited59651-93159651-0931-60
everolimusEverolimus .5 mg/1TabletOralAurobindo Pharma Limited59651-93259651-0932-60

All 69 Everolimus NDCs

Other NDCs under ANDA 218863

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

FDA NDC Directory listings under ANDA 218863
ProductStrengthForm · routeLabelerProduct NDC
EverolimusEverolimus 3 mg/1Tablet, For suspensionOralAmneal Pharmaceuticals NY LLC60219-2280
EverolimusEverolimus 2 mg/1Tablet, For suspensionOralAmneal Pharmaceuticals NY LLC60219-2279

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