NDC codes

FDA NDC Directory
Product NDC (as listed)0185-5050Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00185-5050Add 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 NDC11-digit (billing)PackageCopy
0185-5050-010018550500100185505001100 TABLET in 1 BOTTLE (0185-5050-01)Marketed from Dec 19, 2003
0185-5050-1000185505010001855050101000 TABLET in 1 BOTTLE (0185-5050-10)Marketed from Dec 19, 2003

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)
Metolazone
Generic name (nonproprietary)
metolazone
Active ingredients
Metolazone — 2.5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Sandoz IncNDC labeler code 0185
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076732
Marketing start
Listing expires
Other FDA classes
Increased Diuresis (Physiologic effect)
Identifiers
Product ID 0185-5050_5d900b8f-93d6-46d0-8db9-7fe9e3791a2fSPL ID 5d900b8f-93d6-46d0-8db9-7fe9e3791a2fSPL set ID 0b619826-2567-49d7-8972-b6da5e4467dfRxCUI 197978, 197979, 311671UNII TZ7V40X7VXUPC 0301855600019, 0301855050012, 0301850055012
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

N400185505001 followed by a unit qualifier and the quantity

Package 00185-5050-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Metolazone is 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 is 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 ® tablets and other formulations of metolazone that share its s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0185-5050

What is NDC 0185-5050?
0185-5050 is the product NDC for Metolazone, Metolazone 2.5 mg/1 tablet, listed with the FDA by Sandoz 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?
Sandoz Inc, NDC labeler code 0185. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MetolazoneMetolazone 2.5 mg/1TabletOralSafecor Health LLC48433-06848433-0068-20
MetolazoneMetolazone 5 mg/1TabletOralSafecor Health LLC48433-06948433-0069-20
MetolazoneMetolazone 2.5 mg/1TabletOralMethod Pharmaceuticals, LLC58657-94058657-0940-01
MetolazoneMetolazone 5 mg/1TabletOralMethod Pharmaceuticals, LLC58657-94158657-0941-01
MetolazoneMetolazone 10 mg/1TabletOralMethod Pharmaceuticals, LLC58657-94258657-0942-01
MetolazoneMetolazone 5 mg/1TabletOralMajor Pharmaceuticals0904-752100904-7521-61
MetolazoneMetolazone 2.5 mg/1TabletOralMajor Pharmaceuticals0904-752000904-7520-61
MetolazoneMetolazone 2.5 mg/1TabletOralBryant Ranch Prepack72162-105672162-1056-01
MetolazoneMetolazone 10 mg/1TabletOralBryant Ranch Prepack72162-239172162-2391-01
MetolazoneMetolazone 2.5 mg/1TabletOralBryant Ranch Prepack72162-238972162-2389-01

All 62 Metolazone NDCs

Other NDCs under ANDA 076732

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

FDA NDC Directory listings under ANDA 076732
ProductStrengthForm · routeLabelerProduct NDC
MetolazoneMetolazone 2.5 mg/1TabletOralBryant Ranch Prepack63629-8722
MetolazoneMetolazone 2.5 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-285
MetolazoneMetolazone 2.5 mg/1TabletOralBryant Ranch Prepack72162-1056

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