Prescription drug · ANDA
Metolazone NDC 72888-053
Metolazone 5 mg/1 · Tablet · Oral · Advagen Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72888-053-01 | 72888005301 | 100 TABLET in 1 BOTTLE (72888-053-01)Marketed from Aug 20, 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advagen Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215184
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 72888-053_486ae202-9be8-35ef-e063-6294a90adb8aSPL ID 486ae202-9be8-35ef-e063-6294a90adb8aSPL set ID 6a9c8415-e389-7a9a-73de-532cf3f57ac5RxCUI 197978, 197979, 311671UNII TZ7V40X7VXUPC 0372888053011, 0372888054018, 0372888052014
- 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
N472888005301followed by a unit qualifier and the quantityPackage 72888-0053-01. 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 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.
Other NDCs under ANDA 215184
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Metolazone | Metolazone 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6972 |
| Metolazone | Metolazone 2.5 mg/1 | TabletOral | Advagen Pharma Limited | 72888-052 |
| Metolazone | Metolazone 10 mg/1 | TabletOral | Advagen Pharma Limited | 72888-054 |