Prescription drug · ANDA
Metolazone NDC 0904-7521
Metolazone 5 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7521-61 | 00904752161 | 100 BLISTER PACK in 1 CARTON (0904-7521-61) / 1 TABLET in 1 BLISTER PACKMarketed from Nov 20, 2025 |
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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215616
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 0904-7521_89201e19-d0e8-4192-b2a1-150e9d2c104dSPL ID 89201e19-d0e8-4192-b2a1-150e9d2c104dSPL set ID 89201e19-d0e8-4192-b2a1-150e9d2c104dRxCUI 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
N400904752161followed by a unit qualifier and the quantityPackage 00904-7521-61. 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 metolazone tablets in the treatment of hypertension. See pa…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215616
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 | Major Pharmaceuticals | 0904-7520 |
| Metolazone | Metolazone 10 mg/1 | TabletOral | Ingenus Pharmaceuticals LLC | 50742-351 |
| Metolazone | Metolazone 2.5 mg/1 | TabletOral | Ingenus Pharmaceuticals LLC | 50742-349 |
| Metolazone | Metolazone 5 mg/1 | TabletOral | Ingenus Pharmaceuticals LLC | 50742-350 |