Spironolactone NDC 65162-515

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-515Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0515Add 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
65162-515-03	65162051503	30 TABLET in 1 BOTTLE (65162-515-03)Marketed from Aug 2, 2010
65162-515-06	65162051506	60 TABLET in 1 BOTTLE (65162-515-06)Marketed from Aug 2, 2010
65162-515-09	65162051509	90 TABLET in 1 BOTTLE (65162-515-09)Marketed from Aug 2, 2010
65162-515-10	65162051510	100 TABLET in 1 BOTTLE (65162-515-10)Marketed from Aug 2, 2010
65162-515-11	65162051511	1000 TABLET in 1 BOTTLE (65162-515-11)Marketed from Aug 2, 2010
65162-515-50	65162051550	500 TABLET in 1 BOTTLE (65162-515-50)Marketed from Aug 2, 2010
65162-515-60	65162051560	100 TABLET in 1 BLISTER PACK (65162-515-60)Marketed from Aug 2, 2010

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): Spironolactone
Generic name (nonproprietary): spironolactone
Active ingredients: Spironolactone — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091426
Marketing start: Aug 2, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Aldosterone Antagonists (Mechanism)
Identifiers: Product ID 65162-515_8cdb3181-3666-48aa-a197-fb3a1e082e74SPL ID 8cdb3181-3666-48aa-a197-fb3a1e082e74SPL set ID fb66327e-8261-46ae-b39a-4fa79d520844RxCUI 198222, 198223, 313096UNII 27O7W4T232UPC 0365162515039, 0365162511031, 0365162514032
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

N465162051503 followed by a unit qualifier and the quantity

Package 65162-0515-03. 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 Nov 30, 2020.

Indications (excerpt from the label)

Spironolactone tablets are an aldosterone antagonist indicated for: The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1 ). Use as an add-on therapy for 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 ). The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091426

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

FDA NDC Directory listings under ANDA 091426
Product	Strength	Form · route	Labeler	Product NDC
Spironolactone	Spironolactone 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-0966
Spironolactone	Spironolactone 25 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-102
Spironolactone	Spironolactone 50 mg/1	TabletOral	PharmPak, Inc.	54348-340
Spironolactone	Spironolactone 50 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-514
Spironolactone	Spironolactone 25 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-511
Spironolactone	Spironolactone 100 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-515
Spironolactone	Spironolactone 25 mg/1	TabletOral	QPharma, Inc	42708-126
Spironolactone	Spironolactone 25 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-511
Spironolactone	Spironolactone 50 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-514