What is NDC 10135-765?

10135-765 is the product NDC for Metolazone, Metolazone 2.5 mg/1 tablet, listed with the FDA by Marlex Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Marlex Pharmaceuticals, Inc., NDC labeler code 10135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Metolazone?

61 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Metolazone NDC 10135-765 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)10135-765Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10135-0765Add 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
10135-765-01	1013507650110135076501	100 TABLET in 1 BOTTLE (10135-765-01)Marketed from Dec 1, 2022
10135-765-10	1013507651010135076510	1000 TABLET in 1 BOTTLE (10135-765-10)Marketed from Dec 1, 2022

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 — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Marlex Pharmaceuticals, Inc.NDC labeler code 10135
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216216
Marketing start: Dec 1, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Increased Diuresis (Physiologic effect)
Identifiers: Product ID 10135-765_441c9c41-2125-e622-e063-6294a90adafaSPL ID 441c9c41-2125-e622-e063-6294a90adafaSPL set ID efa5244a-9cdf-a806-e053-2a95a90a912eRxCUI 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

N410135076501 followed by a unit qualifier and the quantity

Package 10135-0765-01. 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 Nov 21, 2025.

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 metolazone in the treatment of hypertension. See package circul…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 10135-765

What is NDC 10135-765?: 10135-765 is the product NDC for Metolazone, Metolazone 2.5 mg/1 tablet, listed with the FDA by Marlex Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Metolazone.
What is the active ingredient?: Metolazone.
Who is the labeler?: Marlex Pharmaceuticals, Inc., NDC labeler code 10135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Metolazone?: 61 other product NDCs are listed under this name. See all Metolazone 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 Metolazone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Metolazone	Metolazone 2.5 mg/1	TabletOral	Safecor Health LLC	48433-068	48433-0068-20
Metolazone	Metolazone 5 mg/1	TabletOral	Safecor Health LLC	48433-069	48433-0069-20
Metolazone	Metolazone 2.5 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-940	58657-0940-01
Metolazone	Metolazone 5 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-941	58657-0941-01
Metolazone	Metolazone 10 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-942	58657-0942-01
Metolazone	Metolazone 5 mg/1	TabletOral	Major Pharmaceuticals	0904-7521	00904-7521-61
Metolazone	Metolazone 2.5 mg/1	TabletOral	Major Pharmaceuticals	0904-7520	00904-7520-61
Metolazone	Metolazone 2.5 mg/1	TabletOral	Bryant Ranch Prepack	72162-1056	72162-1056-01
Metolazone	Metolazone 10 mg/1	TabletOral	Bryant Ranch Prepack	72162-2391	72162-2391-01
Metolazone	Metolazone 2.5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2389	72162-2389-01

All 62 Metolazone NDCs

Other NDCs under ANDA 216216

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

FDA NDC Directory listings under ANDA 216216
Product	Strength	Form · route	Labeler	Product NDC
Metolazone	Metolazone 5 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-766
Metolazone	Metolazone 10 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-767
Metolazone	Metolazone 2.5 mg/1	TabletOral	Aarkish Pharmaceuticals NJ Inc.	81005-124
Metolazone	Metolazone 5 mg/1	TabletOral	Aarkish Pharmaceuticals NJ Inc.	81005-125
Metolazone	Metolazone 10 mg/1	TabletOral	Aarkish Pharmaceuticals NJ Inc.	81005-126