Prescription drug · ANDA
Metolazone NDC 50742-349
Metolazone 2.5 mg/1 · Tablet · Oral · Ingenus Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-349-01 | 50742034901 | 100 TABLET in 1 BOTTLE (50742-349-01)Marketed from Jan 24, 2023 |
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
- Ingenus Pharmaceuticals LLC
- 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 50742-349_40a518ac-5d45-4c61-e063-6294a90a6ec9SPL ID 40a518ac-5d45-4c61-e063-6294a90a6ec9SPL set ID 1e566c10-4498-4f79-8874-4cc8c4216213RxCUI 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
N450742034901followed by a unit qualifier and the quantityPackage 50742-0349-01. 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 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 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7521 |
| Metolazone | Metolazone 2.5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7520 |
| Metolazone | Metolazone 10 mg/1 | TabletOral | Ingenus Pharmaceuticals LLC | 50742-351 |
| Metolazone | Metolazone 5 mg/1 | TabletOral | Ingenus Pharmaceuticals LLC | 50742-350 |