What is NDC 72189-497?

72189-497 is the product NDC for Spironolactone, Spironolactone 25 mg/1 tablet, coated, listed with the FDA by Direct_Rx. It has 2 package NDCs, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Spironolactone?

177 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Spironolactone NDC 72189-497 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-497Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0497Add 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
72189-497-30	7218904973072189049730	30 TABLET, COATED in 1 BOTTLE (72189-497-30)Marketed from Jul 6, 2023
72189-497-90	7218904979072189049790	90 TABLET, COATED in 1 BOTTLE (72189-497-90)Marketed from Jul 6, 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): Spironolactone
Generic name (nonproprietary): spironolactone
Active ingredients: Spironolactone — 25 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040750
Marketing start: Jul 6, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Aldosterone Antagonists (Mechanism)
Identifiers: Product ID 72189-497_4c4b0c1a-d843-08bc-e063-6394a90ad546SPL ID 4c4b0c1a-d843-08bc-e063-6394a90ad546SPL set ID ffd2f3f5-c7c8-0028-e053-6394a90aaf17RxCUI 313096UNII 27O7W4T232
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

N472189049730 followed by a unit qualifier and the quantity

Package 72189-0497-30. 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 Mar 5, 2026.

Indications (excerpt from the label)

1.1 Heart Failure Spironolactone is indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure. Spironolactone is usually administered in conjunction with other heart failure therapies. 1.2 Hypertension Spironolactone is indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive dr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-497

What is NDC 72189-497?: 72189-497 is the product NDC for Spironolactone, Spironolactone 25 mg/1 tablet, coated, listed with the FDA by Direct_Rx. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Spironolactone.
What is the active ingredient?: Spironolactone.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Spironolactone?: 177 other product NDCs are listed under this name. See all Spironolactone 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 Spironolactone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4188	68788-4188-0368788-4188-0668788-4188-09
Spironolactone	Spironolactone 50 mg/1	Tablet, CoatedOral	Coupler LLC	67046-0613	67046-0613-03
Spironolactone	Spironolactone 25 mg/1	Tablet, CoatedOral	Coupler LLC	67046-0744	67046-0744-03
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-087	48433-0087-20
Spironolactone	Spironolactone 50 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-088	48433-0088-20
Spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-089	48433-0089-08
Spironolactone	Spironolactone 100 mg/1	Tablet, CoatedOral	Coupler LLC	67046-1636	67046-1636-03
spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4512	70518-4512-0070518-4512-02
Spironolactone	Spironolactone 25 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-706	64980-0706-0164980-0706-50
Spironolactone	Spironolactone 50 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-707	64980-0707-0164980-0707-50

All 178 Spironolactone NDCs

Other NDCs under ANDA 040750

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

FDA NDC Directory listings under ANDA 040750
Product	Strength	Form · route	Labeler	Product NDC
Spironolactone	Spironolactone 25 mg/1	Tablet, CoatedOral	A-S Medication Solutions	50090-6369
Spironolactone	Spironolactone 50 mg/1	Tablet, CoatedOral	A-S Medication Solutions	50090-6458
Spironolactone	Spironolactone 100 mg/1	Tablet, CoatedOral	A-S Medication Solutions	50090-6539
Spironolactone	Spironolactone 50 mg/1	Tablet, CoatedOral	A-S Medication Solutions	50090-6600
Spironolactone	Spironolactone 25 mg/1	Tablet, CoatedOral	A-S Medication Solutions	50090-7797
Spironolactone	Spironolactone 25 mg/1	Tablet, CoatedOral	Aphena Pharma Solutions - Tennessee, LLC	53401-041
Spironolactone	Spironolactone 50 mg/1	Tablet, CoatedOral	Coupler LLC	67046-0613
Spironolactone	Spironolactone 25 mg/1	Tablet, CoatedOral	Coupler LLC	67046-0744
Spironolactone	Spironolactone 100 mg/1	Tablet, CoatedOral	Coupler LLC	67046-1636
Spironolactone	Spironolactone 25 mg/1	Tablet, CoatedOral	NuCare Pharmaceuticals, Inc.	68071-3967
Spironolactone	Spironolactone 25 mg/1	Tablet, CoatedOral	NuCare Pharmaceuticals,Inc.	68071-3969
Spironolactone	Spironolactone 100 mg/1	Tablet, CoatedOral	Preferred Pharmaceuticals, Inc	68788-8381
Spironolactone	Spironolactone 50 mg/1	Tablet, CoatedOral	Preferred Pharmaceuticals Inc.	68788-8452
Spironolactone	Spironolactone 25 mg/1	Tablet, CoatedOral	Preferred Pharmaceuticals Inc.	68788-8545
Spironolactone	Spironolactone 25 mg/1	Tablet, CoatedOral	Oxford Pharmaceuticals, LLC	69584-852
Spironolactone	Spironolactone 50 mg/1	Tablet, CoatedOral	Oxford Pharmaceuticals, LLC	69584-853
Spironolactone	Spironolactone 100 mg/1	Tablet, CoatedOral	Oxford Pharmaceuticals, LLC	69584-854
Spironolactone	Spironolactone 25 mg/1	Tablet, CoatedOral	REMEDYREPACK INC.	70518-3625
Spironolactone	Spironolactone 50 mg/1	Tablet, CoatedOral	REMEDYREPACK INC.	70518-3655
Spironolactone	Spironolactone 100 mg/1	Tablet, CoatedOral	REMEDYREPACK INC.	70518-3721

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