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	00378040301	100 TABLET in 1 BOTTLE, PLASTIC (0378-0403-01)Marketed from Aug 3, 1979
0378-0403-05	00378040305	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.
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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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