Prescription drug · ANDA
Metoprolol Tartrate NDC 0378-0047
Metoprolol tartrate 100 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-0047-01 | 0037800470100378004701 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0047-01)Marketed from Dec 23, 1993 | |
| 0378-0047-10 | 0037800471000378004710 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0047-10)Marketed from Dec 23, 1993 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Metoprolol Tartrate
- Generic name (nonproprietary)
- metoprolol tartrate
- Active ingredients
- Metoprolol tartrate — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076704
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 0378-0047_57d60035-d408-4f98-932e-2cbbeae5326cSPL ID 57d60035-d408-4f98-932e-2cbbeae5326cSPL set ID 809c6386-0039-42ff-a03e-e42733e229b8RxCUI 866511, 866514, 866924, 1606347, 1606349UNII W5S57Y3A5L
- Pharmacologic class
- beta-Adrenergic Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400378004701followed by a unit qualifier and the quantityPackage 00378-0047-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: • Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • Angina Pectoris. ( 1.2 ) • Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3 ) 1.1 Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension in adult patients, to lower blood pressure. Lowering blood press…
Excerpt only. Read the full label for complete information.
About NDC 0378-0047
- What is NDC 0378-0047?
- 0378-0047 is the product NDC for Metoprolol Tartrate, Metoprolol tartrate 100 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metoprolol Tartrate.
- What is the active ingredient?
- Metoprolol tartrate.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Metoprolol Tartrate?
- 224 other product NDCs are listed under this name. See all Metoprolol Tartrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metoprolol Tartrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Metoprolol Tartratemetoprolol | Metoprolol tartrate 50 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-944 | 60760-0944-60 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4748 | 70518-4748-00 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4714 | 70518-4714-00 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0278 | 55154-0278-00 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0279 | 55154-0279-00 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | TabletOral | Direct_Rx | 72189-677 | 72189-0677-90 |
| Metoprolol Tartratemetoprolol | Metoprolol tartrate 100 mg/1 | TabletOral | Coupler LLC | 67046-1384 | 67046-1384-03 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-928 | 60760-0928-90 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-555 | 72789-0555-90 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-073 | 48433-0073-20 |
Other NDCs under ANDA 076704
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc. | 51079-801 |
| Metoprolol Tartrate | Metoprolol tartrate 37.5 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-4593 |
| Metoprolol Tartrate | Metoprolol tartrate 75 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-4594 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-110 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-109 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-111 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-073 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-074 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-556 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-559 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0278 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-565 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0279 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 55289-382 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-583 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-5356 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-0018 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-595 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-0032 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-5512 |
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