Metolazone
- Product NDC
- 42571-416
- 11-digit product format
- 425710416
- Labeler code
- 42571
- Product ID
- 42571-416_47da5a45-3e85-bb97-e063-6294a90a545c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metolazone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Micro Labs Limited
- Application
- ANDA217563
- Marketing category
- ANDA
- Marketing start
- 2025-03-01
- Substance
- METOLAZONE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metolazone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METOLAZONE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TZ7V40X7VX |
| Rxcui | 197978, 197979, 311671 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42571-416-01 | Metolazone | 100 in 1 CONTAINER | TABLET | 100 | | 2 |
| 42571-416-10 | Metolazone | 1000 in 1 CONTAINER | TABLET | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-416 | METOLAZONE (METOLAZONE) TABLET [MICRO LABS LIMITED] | 1 | Current NDC, 2 package rows | 20250302_9ab471a1-0f71-4452-ba57-518dcc6f9f18.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42571-416-01 | 42571041601 | 100 TABLET in 1 CONTAINER (42571-416-01) | 100 tablet | 2025-03-01 | No | No | Current |
| 42571-416-10 | 42571041610 | 1000 TABLET in 1 CONTAINER (42571-416-10) | 1000 tablet | 2025-03-01 | No | No | Current |