What is NDC 51991-005?

51991-005 is the product NDC for Exemestane, Exemestane 25 mg/1 tablet, film coated, listed with the FDA by Breckenridge Pharmaceutical, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

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 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 51991-005 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)51991-005Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51991-0005Add 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
51991-005-90	5199100059051991000590	90 TABLET, FILM COATED in 1 BOTTLE (51991-005-90)Marketed from Nov 15, 2020

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: Breckenridge Pharmaceutical, Inc.NDC labeler code 51991
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211031
Marketing start: Dec 19, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Aromatase Inhibitors (Mechanism)
Identifiers: Product ID 51991-005_cb46b87b-4bbc-4aed-8656-877a480061afSPL ID cb46b87b-4bbc-4aed-8656-877a480061afSPL set ID 4e3fd382-19f5-4ded-ab22-39d5b1b2f366RxCUI 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

N451991000590 followed by a unit qualifier and the quantity

Package 51991-0005-90. 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 Sep 12, 2024.

Indications (excerpt from the label)

Exemestane tablets are 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51991-005

What is NDC 51991-005?: 51991-005 is the product NDC for Exemestane, Exemestane 25 mg/1 tablet, film coated, listed with the FDA by Breckenridge Pharmaceutical, 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?: 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 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	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	Cipla USA Inc.	69097-316	69097-0316-02
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

Other NDCs under ANDA 211031

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

FDA NDC Directory listings under ANDA 211031
Product	Strength	Form · route	Labeler	Product NDC
Exemestane	Exemestane 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-2056