NDC codes

FDA NDC Directory
Product NDC (as listed)0093-7767Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-7767Add 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
0093-7767-240009377672428 BLISTER PACK in 1 CARTON (0093-7767-24) / 1 TABLET in 1 BLISTER PACK (0093-7767-19)Marketed from Jun 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
Everolimus5 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210050
Marketing start
Marketing end
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 0093-7767_0f7ea770-928b-43b2-8971-849d1d12bbc8SPL ID 0f7ea770-928b-43b2-8971-849d1d12bbc8SPL set ID e3bca36b-29ed-4a2b-a1be-a57b6af805f6RxCUI 845507, 845515, 998189, 1119400UNII 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

N400093776724 followed by a unit qualifier and the quantity

Package 00093-7767-24. 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 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 renal cell carcinoma (RCC)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210050

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

FDA NDC Directory listings under ANDA 210050
ProductStrengthForm · routeLabelerProduct NDC
EverolimusEverolimus 2.5 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-7766
EverolimusEverolimus 7.5 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-7768
EverolimusEverolimus 10 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-7769

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