Metolazone NDC 46708-533

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-533Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0533Add 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
46708-533-31	46708053331	100 TABLET in 1 BOTTLE (46708-533-31)Marketed from Dec 2, 2020
46708-533-91	46708053391	1000 TABLET in 1 BOTTLE (46708-533-91)Marketed from Dec 2, 2020

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 — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213251
Marketing start: Dec 2, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Increased Diuresis (Physiologic effect)
Identifiers: Product ID 46708-533_542fc779-68e0-4f17-b040-971603b518a5SPL ID 542fc779-68e0-4f17-b040-971603b518a5SPL set ID 0f189f26-be06-4030-aebc-d0557b6475fbRxCUI 197978, 197979, 311671UNII TZ7V40X7VX
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

N446708053331 followed by a unit qualifier and the quantity

Package 46708-0533-31. 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 May 28, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Metolazone tablets 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 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 ZAROXOLYN and other formulations of metolazone in the treatment…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213251

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

FDA NDC Directory listings under ANDA 213251
Product	Strength	Form · route	Labeler	Product NDC
Metolazone	Metolazone 5 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-533
Metolazone	Metolazone 10 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-534
Metolazone	Metolazone 2.5 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-532
Metolazone	Metolazone 10 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-534
Metolazone	Metolazone 2.5 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-532