METOLAZONE
- Product NDC
- 81005-125
- 11-digit product format
- 810050125
- Labeler code
- 81005
- Product ID
- 81005-125_4575818c-096e-64e5-e063-6294a90ad3b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metolazone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aarkish Pharmaceuticals NJ Inc.
- Application
- ANDA216216
- Marketing category
- ANDA
- Marketing start
- 2023-08-15
- 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 |
|---|
| 81005-125-01 | METOLAZONE | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 81005-125-10 | METOLAZONE | 1000 in 1 BOTTLE | TABLET | 1000 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81005-125 | METOLAZONE TABLET [AARKISH PHARMACEUTICALS NJ INC.] | 4 | Current NDC, 2 package rows | 20241114_51300edb-2b0f-427c-aeed-bc74a12f52ce.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 |
|---|
| 81005-125-01 | 81005012501 | 100 TABLET in 1 BOTTLE (81005-125-01) | 100 tablet | 2023-08-15 | No | No | Current |
| 81005-125-10 | 81005012510 | 1000 TABLET in 1 BOTTLE (81005-125-10) | 1000 tablet | 2023-08-15 | No | No | Current |