Prescription drug · ANDA
Metolazone NDC 63629-7875
Metolazone 5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-7875-1 | 63629787501 | 30 TABLET in 1 BOTTLE (63629-7875-1)Marketed from Dec 18, 2018 | |
| 63629-7875-2 | 63629787502 | 90 TABLET in 1 BOTTLE (63629-7875-2)Marketed from Apr 29, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076466
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 63629-7875_d764fc31-a1fd-4422-83c8-8504d38b3883SPL ID d764fc31-a1fd-4422-83c8-8504d38b3883SPL set ID 564eccca-2eba-4b6d-b6ab-1439c4c83906RxCUI 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
N463629787501followed by a unit qualifier and the quantityPackage 63629-7875-01. 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 is 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 is 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 metolazone that share its s…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076466
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 | Sandoz Inc | 0185-0055 |
| Metolazone | Metolazone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2850 |
| Metolazone | Metolazone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1050 |
| Metolazone | Metolazone 10 mg/1 | TabletOral | Sandoz Inc | 0185-5600 |
| Metolazone | Metolazone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8733 |