Eplerenone NDC 31722-050

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-050Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0050Add 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
31722-050-30	31722005030	30 TABLET, FILM COATED in 1 BOTTLE (31722-050-30)Marketed from Jun 2, 2023
31722-050-90	31722005090	90 TABLET, FILM COATED in 1 BOTTLE (31722-050-90)Marketed from Jun 2, 2023

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: Camber Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213812
Marketing start: Jun 2, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Aldosterone Antagonists (Mechanism)
Identifiers: Product ID 31722-050_fe285cf1-1e78-943b-e053-6394a90a760dSPL ID fe285cf1-1e78-943b-e053-6394a90a760dSPL set ID 25a1c77c-7008-4b07-af14-5522a282783aRxCUI 351256, 351257UNII 6995V82D0BUPC 0331722049306
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

N431722005030 followed by a unit qualifier and the quantity

Package 31722-0050-30. 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 Jun 15, 2023.

Indications (excerpt from the label)

Eplerenone tablets are an aldosterone antagonist indicated for: • Improving survival of stable patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. ( 1.1 ) • The treatment of hypertension, 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 patients with symptomatic heart failure with reduced ejection fraction (≤40%) (HFrEF) after an acute myocardial infarction (MI). 1.2 Hypertension Eplerenone tablets are indic…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213812

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

FDA NDC Directory listings under ANDA 213812
Product	Strength	Form · route	Labeler	Product NDC
Eplerenone	Eplerenone 25 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-049