Prescription drug · ANDA
Metolazone NDC 43353-931
Metolazone 5 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43353-931-09 | 43353093109 | 9000 TABLET in 1 BOTTLE, PLASTIC (43353-931-09)Marketed from Apr 24, 2014 |
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
- 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 43353-931_5e3b0779-f81b-410e-820e-5cd76dad6bf5SPL ID 5e3b0779-f81b-410e-820e-5cd76dad6bf5SPL set ID 80500d09-e1c5-450a-9806-f4f13843229dRxCUI 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
N443353093109followed by a unit qualifier and the quantityPackage 43353-0931-09. 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 metolazon…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076698
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 | Mylan Pharmaceuticals Inc. | 0378-6172 |
| Metolazone | Metolazone 5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-6173 |
| Metolazone | Metolazone 10 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-6174 |
| Metolazone | Metolazone 2.5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-890 |
| Metolazone | Metolazone 5 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-024 |
| Metolazone | Metolazone 2.5 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-023 |
| Metolazone | Metolazone 2.5 mg/1 | TabletOral | Safecor Health LLC | 48433-068 |
| Metolazone | Metolazone 5 mg/1 | TabletOral | Safecor Health LLC | 48433-069 |