Metoprolol Tartrate and Hydrochlorothiazide
- Product NDC
- 0378-0445
- 11-digit product format
- 003780445
- Labeler code
- 0378
- Product ID
- 0378-0445_771d61ce-0810-4998-b77b-9d3fe58056d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metoprolol tartrate and hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA076792
- Marketing category
- ANDA
- Marketing start
- 2004-08-20
- Substance
- HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
- Active strength
- 50; 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 | 50 mg/1 |
| METOPROLOL TARTRATE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, W5S57Y3A5L |
| Rxcui | 866479, 866482, 866491 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-0445-01 | Metoprolol Tartrate and Hydrochlorothiazide | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-0445 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.] | 12 | Current NDC, Legacy NDC, 1 package rows | 20240413_b6cf0f43-8dc3-4535-b651-daf1f9e0336c.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 |
|---|
| 0378-0445-01 | 00378044501 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0445-01) | 100 tablet | 2004-08-20 | 0000-00-00 | No | No | Current |