METOLAZONE
- Product NDC
- 10135-766
- 11-digit product format
- 101350766
- Labeler code
- 10135
- Product ID
- 10135-766_441c9c41-2125-e622-e063-6294a90adafa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metolazone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA216216
- Marketing category
- ANDA
- Marketing start
- 2022-12-01
- Substance
- METOLAZONE
- Active strength
- 5 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 | 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 |
|---|
| 10135-766-01 | METOLAZONE | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 10135-766-10 | METOLAZONE | 1000 in 1 BOTTLE | TABLET | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-766 | METOLAZONE TABLET [MARLEX PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241016_efa5244a-9cdf-a806-e053-2a95a90a912e.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 |
|---|
| 10135-766-01 | 10135076601 | 100 TABLET in 1 BOTTLE (10135-766-01) | 100 tablet | 2022-12-01 | 0000-00-00 | No | No | Current |
| 10135-766-10 | 10135076610 | 1000 TABLET in 1 BOTTLE (10135-766-10) | 1000 tablet | 2022-12-01 | 0000-00-00 | No | No | Current |