Exemestane NDC 59651-516

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-516Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0516Add 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
59651-516-30	59651051630	30 TABLET, FILM COATED in 1 BOTTLE (59651-516-30)Marketed from May 20, 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): Exemestane
Generic name (nonproprietary): exemestane
Active ingredients: Exemestane — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216454
Marketing start: May 20, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Aromatase Inhibitors (Mechanism)
Identifiers: Product ID 59651-516_498de360-2fc1-4fcf-aa53-54eab01cba43SPL ID 498de360-2fc1-4fcf-aa53-54eab01cba43SPL set ID e24b08eb-4693-41c7-81cb-b536947f7070RxCUI 310261UNII NY22HMQ4BX
Pharmacologic class: Aromatase Inhibitor

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

N459651051630 followed by a unit qualifier and the quantity

Package 59651-0516-30. 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 Apr 25, 2025.

Indications (excerpt from the label)

Exemestane is an aromatase inhibitor indicated for: adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ). treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2 ). 1.1 Adjuvant Treatment of Postmenopausal Women Exemestane tablets are indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216454

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

FDA NDC Directory listings under ANDA 216454
Product	Strength	Form · route	Labeler	Product NDC
Exemestane	Exemestane 25 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	72603-329