What is NDC 0054-0472?

0054-0472 is the product NDC for Everolimus, Everolimus .75 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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?

67 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 0054-0472 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0472Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0472Add 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
0054-0472-21	00054047221	60 TABLET in 1 BOTTLE (0054-0472-21)Marketed from Mar 10, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — .75 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206133
Marketing start: Mar 10, 2020
Listing expires: Dec 31, 2026
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 0054-0472_496ea375-42a1-422e-88ad-0b1c6df703aaSPL ID 496ea375-42a1-422e-88ad-0b1c6df703aaSPL set ID cf2dd54b-7a1d-4401-9a01-75e68235e433RxCUI 977427, 977434, 977438, 2056895UNII 9HW64Q8G6GUPC 0300540471217, 0300540470210, 0300540472214
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

N400054047221 followed by a unit qualifier and the quantity

Package 00054-0472-21. 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 Sep 3, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: • Kidney Transplant : at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids. ( 1.1 ) • Liver Transplant : Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids. ( 1.2 , 5.5 ) Limitations of Use : Safety and efficacy have not been established in the following: • Kidney transplant patients at high immunologic risk. ( 1.3 ) • Recipients of transplanted organs other than kidney or liver. ( 1.3 , 5.7 ) • Pediatric patients (less than 18 years). ( 1.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0054-0472

What is NDC 0054-0472?: 0054-0472 is the product NDC for Everolimus, Everolimus .75 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. 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?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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?: 67 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 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 7.5 mg/1	TabletOral	Novugen Pharma (USA) LLC.	82293-032	82293-0032-1082293-0032-2182293-0032-31
everolimus	Everolimus 10 mg/1	TabletOral	Novugen Pharma (USA) LLC.	82293-033	82293-0033-1082293-0033-2182293-0033-31
everolimus	Everolimus .25 mg/1	TabletOral	Aurobindo Pharma Limited	59651-931	59651-0931-60
everolimus	Everolimus .5 mg/1	TabletOral	Aurobindo Pharma Limited	59651-932	59651-0932-60

All 68 Everolimus NDCs

Other NDCs under ANDA 206133

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

FDA NDC Directory listings under ANDA 206133
Product	Strength	Form · route	Labeler	Product NDC
Everolimus	Everolimus .25 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0470
Everolimus	Everolimus 1 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0604
Everolimus	Everolimus .5 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0471