Metoprolol Tartrate
- Product NDC
- 0378-4594
- 11-digit product format
- 003784594
- Labeler code
- 0378
- Product ID
- 0378-4594_57d60035-d408-4f98-932e-2cbbeae5326c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metoprolol tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA076704
- Marketing category
- ANDA
- Marketing start
- 2016-03-29
- Substance
- METOPROLOL TARTRATE
- Active strength
- 75 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METOPROLOL TARTRATE | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W5S57Y3A5L |
| Rxcui | 866511, 866514, 866924, 1606347, 1606349 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-4594-01 | Metoprolol Tartrate | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 31 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METOPROLOL TARTRATE | ACTIVE INGREDIENT | W5S57Y3A5L | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
| METOPROLOL | ACTIVE MOIETY | GEB06NHM23 | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-4594 | METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 31 | Current NDC, Legacy NDC, 1 package rows | 20240302_809c6386-0039-42ff-a03e-e42733e229b8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-4594-01 | 00378459401 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4594-01) | 2016-03-29 | 0000-00-00 | No | No | Current |