Metolazone
- Product NDC
- 76385-138
- 11-digit product format
- 763850138
- Labeler code
- 76385
- Product ID
- 76385-138_545bb32a-23cf-4e31-a1eb-3c9636a5b592
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metolazone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA214799
- Marketing category
- ANDA
- Marketing start
- 2021-03-30
- Substance
- METOLAZONE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metolazone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METOLAZONE | 10 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 |
|---|
| 76385-138-01 | Metolazone | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76385-138 | METOLAZONE TABLET [BAYSHORE PHARMACEUTICALS LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20210903_c6fe5426-a184-44b8-a555-621d72aa5b9f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76385-138-01 | 76385013801 | 100 TABLET in 1 BOTTLE (76385-138-01) | 100 tablet | 2021-03-30 | 0000-00-00 | No | No | Current |