What is NDC 71335-2355?

71335-2355 is the product NDC for Eplerenone, Eplerenone 25 mg/1 tablet, coated, listed with the FDA by Bryant Ranch Prepack. It has 2 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Eplerenone?

18 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Eplerenone NDC 71335-2355 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-2355Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-2355Add 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
71335-2355-1	71335235501	90 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-2355-1)Marketed from May 28, 2024
71335-2355-2	71335235502	30 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-2355-2)Marketed from May 28, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 25 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207842
Marketing start: Nov 8, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Aldosterone Antagonists (Mechanism)
Identifiers: Product ID 71335-2355_3b033db4-feaa-4c28-876e-8042b0f2cf60SPL ID 3b033db4-feaa-4c28-876e-8042b0f2cf60SPL set ID 2002cf90-2d4a-43b1-bcd6-c447cbc7010fRxCUI 351256UNII 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

N471335235501 followed by a unit qualifier and the quantity

Package 71335-2355-01. 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 May 28, 2024.

Indications (excerpt from the label)

Eplerenone is 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 indicated for the…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2355

What is NDC 71335-2355?: 71335-2355 is the product NDC for Eplerenone, Eplerenone 25 mg/1 tablet, coated, listed with the FDA by Bryant Ranch Prepack. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Eplerenone.
What is the active ingredient?: Eplerenone.
Who is the labeler?: Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Eplerenone?: 18 other product NDCs are listed under this name. See all Eplerenone 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 Eplerenone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Eplerenone	Eplerenone 25 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	59762-1107	59762-1107-0259762-1107-03
Eplerenone	Eplerenone 50 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	59762-1108	59762-1108-0159762-1108-02
Eplerenone	Eplerenone 25 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-173	16571-0173-0316571-0173-09
Eplerenone	Eplerenone 50 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-174	16571-0174-0316571-0174-09
Eplerenone	Eplerenone 25 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-049	31722-0049-3031722-0049-90
Eplerenone	Eplerenone 50 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-050	31722-0050-3031722-0050-90
Eplerenone	Eplerenone 25 mg/1	Tablet, CoatedOral	AvKARE	42291-454	42291-0454-90
Eplerenone	Eplerenone 50 mg/1	Tablet, CoatedOral	AvKARE	42291-455	42291-0455-90
Eplerenone	Eplerenone 25 mg/1	Tablet, CoatedOral	Westminster Pharmaceuticals, LLC	69367-307	69367-0307-0969367-0307-30
Eplerenone	Eplerenone 50 mg/1	Tablet, CoatedOral	Westminster Pharmaceuticals, LLC	69367-308	69367-0308-0969367-0308-30

All 19 Eplerenone NDCs

Other NDCs under ANDA 207842

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

FDA NDC Directory listings under ANDA 207842
Product	Strength	Form · route	Labeler	Product NDC
Eplerenone	Eplerenone 25 mg/1	Tablet, CoatedOral	Westminster Pharmaceuticals, LLC	69367-307
Eplerenone	Eplerenone 50 mg/1	Tablet, CoatedOral	Westminster Pharmaceuticals, LLC	69367-308
Eplerenone	Eplerenone 50 mg/1	Tablet, CoatedOral	Proficient Rx LP	71205-864
Eplerenone	Eplerenone 25 mg/1	Tablet, CoatedOral	Proficient Rx LP	71205-863
Eplerenone	Eplerenone 25 mg/1	Tablet, CoatedOral	AvKARE	42291-454
Eplerenone	Eplerenone 50 mg/1	Tablet, CoatedOral	AvKARE	42291-455