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 NDC11-digit (billing)PackageCopy
59651-516-30596510516305965105163030 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 LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216454
Marketing start
Listing expires
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 .

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)

About NDC 59651-516

What is NDC 59651-516?
59651-516 is the product NDC for Exemestane, Exemestane 25 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Exemestane.
What is the active ingredient?
Exemestane.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Exemestane?
10 other product NDCs are listed under this name. See all Exemestane 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 Exemestane NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ExemestaneExemestane 25 mg/1Tablet, CoatedOralOPKO Pharmaceuticals, LLC70301-201770301-2017-01
ExemestaneExemestane 25 mg/1Tablet, Film coatedOralNorthStar Rx LLC72603-32972603-0329-01
ExemestaneExemestane 25 mg/1Tablet, Film coatedOralFlorida Pharmaceutical Products, LLC71921-19071921-0190-33
ExemestaneExemestane 25 mg/1Tablet, Film coatedOralBreckenridge Pharmaceutical, Inc.51991-00551991-0005-90
ExemestaneExemestane 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-205663629-2056-01
ExemestaneExemestane 25 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-38368382-0383-06
ExemestaneExemestane 25 mg/1TabletOralZydus Lifesciences Limited70771-137470771-1374-03
ExemestaneExemestane 25 mg/1TabletOralCipla USA Inc.69097-31669097-0316-02
ExemestaneExemestane 25 mg/1TabletOralUpsher-Smith Laboratories, Inc.0832-059500832-0595-30
ExemestaneExemestane 25 mg/1Tablet, Sugar coatedOralMylan Pharmaceuticals Inc.59762-285859762-2858-01

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
ProductStrengthForm · routeLabelerProduct NDC
ExemestaneExemestane 25 mg/1Tablet, Film coatedOralNorthStar Rx LLC72603-329

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