What is NDC 0378-2146?

0378-2146 is the product NDC for Spironolactone, Spironolactone 25 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 0378-2146 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-2146Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-2146Add 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
0378-2146-01	0037821460100378214601	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2146-01)Marketed from Feb 3, 1981
0378-2146-05	0037821460500378214605	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2146-05)Marketed from Feb 3, 1981

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040424
Marketing start: Feb 3, 1981
Listing expires: Dec 31, 2027
Other FDA classes: Aldosterone Antagonists (Mechanism)
Identifiers: Product ID 0378-2146_b78b6da0-ce99-4c8f-bf36-c4e19b34dfd9SPL ID b78b6da0-ce99-4c8f-bf36-c4e19b34dfd9SPL set ID beaf74db-4159-3b59-ef99-575c3ac99aa1RxCUI 198222, 198223, 313096UNII 27O7W4T232UPC 0303782146011
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

N400378214601 followed by a unit qualifier and the quantity

Package 00378-2146-01. 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 Mar 12, 2026.

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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-2146

What is NDC 0378-2146?: 0378-2146 is the product NDC for Spironolactone, Spironolactone 25 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 040424

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

FDA NDC Directory listings under ANDA 040424
Product	Strength	Form · route	Labeler	Product NDC
Spironolactone	Spironolactone 50 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-0243
Spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-0437
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-087
Spironolactone	Spironolactone 50 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-088
Spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-089
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-103
Spironolactone	Spironolactone 50 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-979
Spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-980
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-5517
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	67544-310
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2150