Prescription drug · ANDA
Metolazone NDC 81005-124
Metolazone 2.5 mg/1 · Tablet · Oral · Aarkish Pharmaceuticals NJ Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81005-124-01 | 81005012401 | 100 TABLET in 1 BOTTLE (81005-124-01)Marketed from Aug 15, 2023 | |
| 81005-124-10 | 81005012410 | 1000 TABLET in 1 BOTTLE (81005-124-10)Marketed from Aug 15, 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216216
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 81005-124_4575818c-096e-64e5-e063-6294a90ad3b7SPL ID 4575818c-096e-64e5-e063-6294a90ad3b7SPL set ID 51300edb-2b0f-427c-aeed-bc74a12f52ceRxCUI 197978, 197979, 311671UNII TZ7V40X7VXUPC 0381005124107, 0381005125104, 0381005124015, 0381005126101, 0381005126019
- 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
N481005012401followed by a unit qualifier and the quantityPackage 81005-0124-01. 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 in the treatment of hypertension. See package ci…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216216
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 | Aarkish Pharmaceuticals NJ Inc. | 81005-125 |
| Metolazone | Metolazone 10 mg/1 | TabletOral | Aarkish Pharmaceuticals NJ Inc. | 81005-126 |
| Metolazone | Metolazone 2.5 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-765 |
| Metolazone | Metolazone 5 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-766 |
| Metolazone | Metolazone 10 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-767 |