NDC codes

FDA NDC Directory
Product NDC (as listed)51991-824Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51991-0824Add 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
51991-824-2851991082428519910824284 BLISTER PACK in 1 CARTON (51991-824-28) / 7 TABLET in 1 BLISTER PACK (51991-824-99)Marketed from Oct 1, 2021
51991-824-33519910824335199108243330 TABLET in 1 BOTTLE (51991-824-33)Marketed from Jun 5, 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)
Everolimus
Generic name (nonproprietary)
everolimus
Active ingredients
Everolimus — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Breckenridge Pharmaceutical, Inc.NDC labeler code 51991
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205426
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 51991-824_fade73fb-a367-4c53-83dd-1352c3ad807bSPL ID fade73fb-a367-4c53-83dd-1352c3ad807bSPL set ID 01f7b5fb-be0d-4adf-acd2-6899018de966RxCUI 845507, 845515, 998189, 1119400, 1308428, 1308430, 1308432UNII 9HW64Q8G6GUPC 0351991822332, 0351991823339, 0351991824336, 0351991821335
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

N451991082428 followed by a unit qualifier and the quantity

Package 51991-0824-28. 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)

1. INDICATIONS AND USAGE Everolimus tablets are a kinase inhibitor indicated for the treatment of: Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ( 1.1 ) Adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Limitations of Use: Everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors. ( 1.2 ) Adults with advanced re…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51991-824

What is NDC 51991-824?
51991-824 is the product NDC for Everolimus, Everolimus 10 mg/1 tablet, listed with the FDA by Breckenridge Pharmaceutical, Inc.. 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?
Breckenridge Pharmaceutical, Inc., NDC labeler code 51991. 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 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
ProductStrengthForm · routeLabelerProduct NDC
EverolimusEverolimus 2.5 mg/1TabletOralNatco Pharma Limited63850-0058
EverolimusEverolimus 5 mg/1TabletOralNatco Pharma Limited63850-0059
EverolimusEverolimus 7.5 mg/1TabletOralNatco Pharma Limited63850-0060
EverolimusEverolimus 10 mg/1TabletOralNatco Pharma Limited63850-0061
EverolimusEverolimus 2.5 mg/1TabletOralBreckenridge Pharmaceutical, Inc.51991-821
EverolimusEverolimus 5 mg/1TabletOralBreckenridge Pharmaceutical, Inc.51991-822
EverolimusEverolimus 7.5 mg/1TabletOralBreckenridge Pharmaceutical, Inc.51991-823
YulithiraeverolimusEverolimus 5 mg/1TabletOralCivicaScript, LLC82249-611
YulithiraeverolimusEverolimus 2.5 mg/1TabletOralCivicaScript, LLC82249-610
YulithiraeverolimusEverolimus 7.5 mg/1TabletOralCivicaScript, LLC82249-612
YulithiraeverolimusEverolimus 10 mg/1TabletOralCivicaScript, LLC82249-613

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