Prescription drug · ANDA
Metolazone NDC 69292-566
Metolazone 10 mg/1 · Tablet · Oral · Amici Pharma, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69292-566-01 | 69292056601 | 100 TABLET in 1 BOTTLE (69292-566-01)Marketed from May 15, 2021 | |
| 69292-566-10 | 69292056610 | 1000 TABLET in 1 BOTTLE (69292-566-10)Marketed from May 15, 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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amici Pharma, Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213827
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 69292-566_4e6cbb9b-9a10-2771-e063-6394a90aef38SPL ID 4e6cbb9b-9a10-2771-e063-6394a90aef38SPL set ID cbfa3d5c-cce9-4afa-b064-06f1e1041eacRxCUI 197978, 197979, 311671UNII TZ7V40X7VXUPC 0369292566015, 0369292564011, 0369292562017
- 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
N469292056601followed by a unit qualifier and the quantityPackage 69292-0566-01. 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 hy…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213827
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 | Bryant Ranch Prepack | 72162-2389 |
| Metolazone | Metolazone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2390 |
| Metolazone | Metolazone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2391 |
| Metolazone | Metolazone 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6802 |
| Metolazone | Metolazone 2.5 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-740 |
| Metolazone | Metolazone 5 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-741 |
| Metolazone | Metolazone 10 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-742 |
| Metolazone | Metolazone 2.5 mg/1 | TabletOral | American Health Packaging | 60687-624 |
| Metolazone | Metolazone 5 mg/1 | TabletOral | American Health Packaging | 60687-635 |
| Metolazone | Metolazone 10 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-942 |
| Metolazone | Metolazone 2.5 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-940 |
| Metolazone | Metolazone 5 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-941 |
| Metolazone | Metolazone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1944 |
| Metolazone | Metolazone 10 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-433 |
| Metolazone | Metolazone 2.5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-431 |
| Metolazone | Metolazone 5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-432 |
| Metolazone | Metolazone 2.5 mg/1 | TabletOral | Amici Pharma, Inc | 69292-562 |
| Metolazone | Metolazone 5 mg/1 | TabletOral | Amici Pharma, Inc | 69292-564 |