What is NDC 53401-041?

53401-041 is the product NDC for Spironolactone, Spironolactone 25 mg/1 tablet, coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. 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 53401-041 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53401-041Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53401-0041Add 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
53401-041-30	5340100413053401004130	30 TABLET, COATED in 1 BOTTLE (53401-041-30)Marketed from Oct 5, 2026
53401-041-45	5340100414553401004145	45 TABLET, COATED in 1 BOTTLE (53401-041-45)Marketed from Oct 5, 2026
53401-041-60	5340100416053401004160	90 TABLET, COATED in 1 BOTTLE (53401-041-60)Marketed from Oct 5, 2026
53401-041-80	5340100418053401004180	180 TABLET, COATED in 1 BOTTLE (53401-041-80)Marketed from Oct 5, 2026

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: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 53401
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040750
Marketing start: Jan 4, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Aldosterone Antagonists (Mechanism)
Identifiers: Product ID 53401-041_5d407dcd-e4fa-31b3-e063-6394a90a24e3SPL ID 5d407dcd-e4fa-31b3-e063-6394a90a24e3
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

N453401004130 followed by a unit qualifier and the quantity

Package 53401-0041-30. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 53401-041

What is NDC 53401-041?: 53401-041 is the product NDC for Spironolactone, Spironolactone 25 mg/1 tablet, coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. 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 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
Spironolactone	Spironolactone 100 mg/1	Tablet, CoatedOral	Direct_Rx	72189-495

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