NDC codes

FDA NDC Directory
Product NDC (as listed)51079-023Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51079-0023Add 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
51079-023-205107900232051079002320100 BLISTER PACK in 1 CARTON (51079-023-20) / 1 TABLET in 1 BLISTER PACK (51079-023-01)Marketed from Apr 15, 2005

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
Mylan Institutional Inc.NDC labeler code 51079
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076698
Marketing start
Listing expires
Other FDA classes
Increased Diuresis (Physiologic effect)
Identifiers
Product ID 51079-023_3a866716-12c7-4380-e063-6394a90ae975SPL ID 3a866716-12c7-4380-e063-6394a90ae975SPL set ID e5fe856e-7fd6-47fb-87f7-7c1c621f50a0RxCUI 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

N451079002320 followed by a unit qualifier and the quantity

Package 51079-0023-20. 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 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 ® tablets and other formulations of metolazone th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51079-023

What is NDC 51079-023?
51079-023 is the product NDC for Metolazone, Metolazone 2.5 mg/1 tablet, listed with the FDA by Mylan Institutional Inc.. It has 1 package NDC, 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?
Mylan Institutional Inc., NDC labeler code 51079. 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 076698

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

FDA NDC Directory listings under ANDA 076698
ProductStrengthForm · routeLabelerProduct NDC
MetolazoneMetolazone 2.5 mg/1TabletOralMylan Pharmaceuticals Inc.0378-6172
MetolazoneMetolazone 5 mg/1TabletOralMylan Pharmaceuticals Inc.0378-6173
MetolazoneMetolazone 10 mg/1TabletOralMylan Pharmaceuticals Inc.0378-6174
MetolazoneMetolazone 2.5 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC43353-890
MetolazoneMetolazone 5 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC43353-931
MetolazoneMetolazone 2.5 mg/1TabletOralSafecor Health LLC48433-068
MetolazoneMetolazone 5 mg/1TabletOralSafecor Health LLC48433-069
MetolazoneMetolazone 5 mg/1TabletOralMylan Institutional Inc.51079-024

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