METOLAZONE
- Product NDC
- 46708-534
- 11-digit product format
- 467080534
- Labeler code
- 46708
- Product ID
- 46708-534_542fc779-68e0-4f17-b040-971603b518a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METOLAZONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA213251
- Marketing category
- ANDA
- Marketing start
- 2020-12-02
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-534-31 | METOLAZONE | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 46708-534-91 | METOLAZONE | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-534 | METOLAZONE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240530_0f189f26-be06-4030-aebc-d0557b6475fb.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 |
|---|
| 46708-534-31 | 46708053431 | 100 TABLET in 1 BOTTLE (46708-534-31) | 100 tablet | 2020-12-02 | 0000-00-00 | No | No | Current |
| 46708-534-91 | 46708053491 | 1000 TABLET in 1 BOTTLE (46708-534-91) | 1000 tablet | 2020-12-02 | 0000-00-00 | No | No | Current |