What is NDC 0378-0403?

0378-0403 is the product NDC for Spironolactone and Hydrochlorothiazide, Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Spironolactone, Hydrochlorothiazide.

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 and Hydrochlorothiazide?

11 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Spironolactone and Hydrochlorothiazide NDC 0378-0403

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-0403Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-0403Add 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
0378-0403-01	0037804030100378040301	100 TABLET in 1 BOTTLE, PLASTIC (0378-0403-01)Marketed from Aug 3, 1979
0378-0403-05	0037804030500378040305	500 TABLET in 1 BOTTLE, PLASTIC (0378-0403-05)Marketed from Aug 3, 1979

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 and Hydrochlorothiazide
Generic name (nonproprietary): spironolactone and hydrochlorothiazide
Active ingredients: Spironolactone — 25 mg/1Hydrochlorothiazide — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 086513
Marketing start: Aug 3, 1979
Listing expires: Dec 31, 2027
Other FDA classes: Aldosterone Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 0378-0403_d37da837-e7ff-475b-b7fc-ae8d8ef5f020SPL ID d37da837-e7ff-475b-b7fc-ae8d8ef5f020SPL set ID 0c8c973f-13a2-4883-8316-4006398e2931RxCUI 198224UNII 27O7W4T232, 0J48LPH2TH
Pharmacologic class: Aldosterone Antagonist; Thiazide Diuretic

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

N400378040301 followed by a unit qualifier and the quantity

Package 00378-0403-01. 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 11, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions section). Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described below. Unnecessary use of this drug should be avoided. Spironolactone and hydrochlorothiazide tablets are indicated for: Edematous conditions for patients with: Congestive heart failure: • For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures; • The treatment of diuretic-induced hypokalemia in patients with co…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-0403

What is NDC 0378-0403?: 0378-0403 is the product NDC for Spironolactone and Hydrochlorothiazide, Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 tablet, 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 and Hydrochlorothiazide.
What is the active ingredient?: Spironolactone, Hydrochlorothiazide.
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 and Hydrochlorothiazide?: 11 other product NDCs are listed under this name. See all Spironolactone and Hydrochlorothiazide 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 and Hydrochlorothiazide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Spironolactone and hydrochlorothiazide	Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Advagen Pharma Ltd.	72888-040	72888-0040-0172888-0040-0272888-0040-03
Spironolactone and Hydrochlorothiazide	Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Safecor Health LLC	48433-090	48433-0090-20
Spironolactone and Hydrochlorothiazide	Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Prasco Laboratories	66993-188	66993-0188-02
Spironolactone and Hydrochlorothiazide	Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Mylan Institutional Inc.	42292-017	42292-0017-20
Spironolactone and Hydrochlorothiazide	Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	53489-144	53489-0144-0153489-0144-0553489-0144-10
Spironolactone and Hydrochlorothiazide	Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Bryant Ranch Prepack	63629-1068	63629-1068-01
Spironolactone and Hydrochlorothiazide	Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Bryant Ranch Prepack	63629-1069	63629-1069-01
Spironolactone and Hydrochlorothiazide	Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Bryant Ranch Prepack	63629-1071	63629-1071-0163629-1071-0263629-1071-03
Spironolactone and Hydrochlorothiazide	Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Bryant Ranch Prepack	71335-2202	71335-2202-01
Spironolactone and Hydrochlorothiazide	Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Bryant Ranch Prepack	71335-2674	71335-2674-0171335-2674-0271335-2674-03

All 12 Spironolactone and Hydrochlorothiazide NDCs

Other NDCs under ANDA 086513

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

FDA NDC Directory listings under ANDA 086513
Product	Strength	Form · route	Labeler	Product NDC
Spironolactone and Hydrochlorothiazide	Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Mylan Institutional Inc.	42292-017
Spironolactone and Hydrochlorothiazide	Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Safecor Health LLC	48433-090