NDC codes

FDA NDC Directory
Product NDC (as listed)49884-283Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49884-0283Add 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
49884-283-0249884028302498840283026 BLISTER PACK in 1 CARTON (49884-283-02) / 10 TABLET in 1 BLISTER PACK (49884-283-52)Marketed from Jan 26, 2022

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)
Everolimus
Generic name (nonproprietary)
everolimus
Active ingredients
Everolimus — 1 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Par Health USA, LLCNDC labeler code 49884
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205775
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 49884-283_7523ed83-6f81-4cc8-b815-e646ffa1dd80SPL ID 7523ed83-6f81-4cc8-b815-e646ffa1dd80
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

N449884028302 followed by a unit qualifier and the quantity

Package 49884-0283-02. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 49884-283

What is NDC 49884-283?
49884-283 is the product NDC for Everolimus, Everolimus 1 mg/1 tablet, listed with the FDA by Par Health USA, 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?
Par Health USA, LLC, NDC labeler code 49884. 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
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 .75 mg/1TabletOralAurobindo Pharma Limited59651-93359651-0933-60
everolimusEverolimus .25 mg/1TabletOralAurobindo Pharma Limited59651-93159651-0931-60

All 66 Everolimus NDCs

Other NDCs under ANDA 205775

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

FDA NDC Directory listings under ANDA 205775
ProductStrengthForm · routeLabelerProduct NDC
EverolimusEverolimus .5 mg/1TabletOralPar Health USA, LLC49884-159

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