What is NDC 69097-316?

69097-316 is the product NDC for Exemestane, Exemestane 25 mg/1 tablet, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Exemestane NDC 69097-316 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-316Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0316Add 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
69097-316-02	6909703160269097031602	30 TABLET in 1 BOTTLE (69097-316-02)Marketed from Apr 27, 2018

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
Route: Oral
Labeler: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210323
Marketing start: Apr 27, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Aromatase Inhibitors (Mechanism)
Identifiers: Product ID 69097-316_60b57295-ef43-4721-94c4-58a4c5689420SPL ID 60b57295-ef43-4721-94c4-58a4c5689420SPL set ID abde1ccd-0ec9-40d4-b205-fbc00f5878b9RxCUI 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

N469097031602 followed by a unit qualifier and the quantity

Package 69097-0316-02. 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 Feb 9, 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, USP 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, USP 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-316

What is NDC 69097-316?: 69097-316 is the product NDC for Exemestane, Exemestane 25 mg/1 tablet, listed with the FDA by Cipla USA Inc.. 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?: Cipla USA Inc., NDC labeler code 69097. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Exemestane	Exemestane 25 mg/1	Tablet, CoatedOral	OPKO Pharmaceuticals, LLC	70301-2017	70301-2017-01
Exemestane	Exemestane 25 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	72603-329	72603-0329-01
Exemestane	Exemestane 25 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-516	59651-0516-30
Exemestane	Exemestane 25 mg/1	Tablet, Film coatedOral	Florida Pharmaceutical Products, LLC	71921-190	71921-0190-33
Exemestane	Exemestane 25 mg/1	Tablet, Film coatedOral	Breckenridge Pharmaceutical, Inc.	51991-005	51991-0005-90
Exemestane	Exemestane 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-2056	63629-2056-01
Exemestane	Exemestane 25 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-383	68382-0383-06
Exemestane	Exemestane 25 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1374	70771-1374-03
Exemestane	Exemestane 25 mg/1	TabletOral	Upsher-Smith Laboratories, Inc.	0832-0595	00832-0595-30
Exemestane	Exemestane 25 mg/1	Tablet, Sugar coatedOral	Mylan Pharmaceuticals Inc.	59762-2858	59762-2858-01