Metoprolol Tartrate and Hydrochlorothiazide
- Product NDC
- 46708-116
- 11-digit product format
- 467080116
- Labeler code
- 46708
- Product ID
- 46708-116_5afb35ed-f222-47c7-ac02-3b1d062b09d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metoprolol Tartrate and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA202870
- Marketing category
- ANDA
- Marketing start
- 2013-09-17
- Substance
- HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
- Active strength
- 25; 100 mg/1; mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metoprolol Tartrate and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 25 mg/1 |
| METOPROLOL TARTRATE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W5S57Y3A5L, 0J48LPH2TH |
| Rxcui | 866479, 866482, 866491 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-116-10 | Metoprolol Tartrate and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 46708-116-30 | Metoprolol Tartrate and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 46708-116-50 | Metoprolol Tartrate and Hydrochlorothiazide | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-116 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 3 package rows | 20230119_538ea34a-1ac3-48c8-b841-43be09285e12.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 |
|---|
| 46708-116-10 | 46708011610 | 100 TABLET in 1 BOTTLE (46708-116-10) | 100 tablet | 2013-09-17 | 0000-00-00 | No | No | Current |
| 46708-116-30 | 46708011630 | 30 TABLET in 1 BOTTLE (46708-116-30) | 30 tablet | 2013-09-17 | 0000-00-00 | No | No | Current |
| 46708-116-50 | 46708011650 | 500 TABLET in 1 BOTTLE (46708-116-50) | 500 tablet | 2013-09-17 | 0000-00-00 | No | No | Current |