Metolazone NDC 76385-138

NDC codes

FDA NDC Directory

Product NDC (as listed)76385-138Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76385-0138Add 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
76385-138-01	76385013801	100 TABLET in 1 BOTTLE (76385-138-01)Marketed from Mar 30, 2021

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): Metolazone
Generic name (nonproprietary): metolazone
Active ingredients: Metolazone — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Unichem Pharmaceuticals (USA), Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214799
Marketing start: Mar 30, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Increased Diuresis (Physiologic effect)
Identifiers: Product ID 76385-138_545bb32a-23cf-4e31-a1eb-3c9636a5b592SPL ID 545bb32a-23cf-4e31-a1eb-3c9636a5b592SPL set ID c6fe5426-a184-44b8-a555-621d72aa5b9fRxCUI 197978, 197979, 311671UNII TZ7V40X7VXUPC 0376385136017, 0376385137014, 0376385138011
Pharmacologic class: Thiazide-like 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

N476385013801 followed by a unit qualifier and the quantity

Package 76385-0138-01. 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 Dec 11, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Metolazone tablets, USP, are indicated for the treatment of salt and water retention including: edema accompanying congestive heart failure; edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. Metolazone tablets, USP, are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. MYKROX Tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if MYKROX Tablets are to be substituted for metolazone tablets, USP, in the treatment of hypert…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214799

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

FDA NDC Directory listings under ANDA 214799
Product	Strength	Form · route	Labeler	Product NDC
Metolazone	Metolazone 2.5 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	76385-136
Metolazone	Metolazone 5 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	76385-137