Eplerenone NDC 51991-878

NDC codes

FDA NDC Directory

Product NDC (as listed)51991-878Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51991-0878Add 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
51991-878-11	51991087811	10 BLISTER PACK in 1 CARTON (51991-878-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (51991-878-99)Marketed from Sep 18, 2018
51991-878-33	51991087833	30 TABLET, FILM COATED in 1 BOTTLE (51991-878-33)Marketed from Sep 18, 2018
51991-878-90	51991087890	90 TABLET, FILM COATED in 1 BOTTLE (51991-878-90)Marketed from Sep 18, 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): Eplerenone
Generic name (nonproprietary): eplerenone
Active ingredients: Eplerenone — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Breckenridge Pharmaceutical, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208283
Marketing start: Sep 18, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Aldosterone Antagonists (Mechanism)
Identifiers: Product ID 51991-878_546c0ded-8c22-4840-b369-a3029dedc299SPL ID 546c0ded-8c22-4840-b369-a3029dedc299SPL set ID e2a51c12-bdc2-4b3b-8e9e-bf363c2817edRxCUI 351256, 351257UNII 6995V82D0B
Pharmacologic class: Aldosterone Antagonist

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

N451991087811 followed by a unit qualifier and the quantity

Package 51991-0878-11. 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 Mar 17, 2026.

Indications (excerpt from the label)

Eplerenone Tablets are an aldosterone antagonist indicated for: Improving survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. ( 1.1 ) The treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.2 ) 1.1 Heart Failure Post-Myocardial Infarction Eplerenone Tablets are indicated to improve survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (≤40%) (HFrEF) after an acute myocardial infarction (MI). 1.2 Hypertension Eplerenone …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208283

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

FDA NDC Directory listings under ANDA 208283
Product	Strength	Form · route	Labeler	Product NDC
Eplerenone	Eplerenone 25 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-451
Eplerenone	Eplerenone 25 mg/1	Tablet, Film coatedOral	Breckenridge Pharmaceutical, Inc.	51991-877