Prescription drug · ANDA
Metoprolol Tartrate and Hydrochlorothiazide NDC 62756-369
Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 50 mg/1 · Tablet · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62756-369-08 | 62756036908 | 100 TABLET in 1 BOTTLE (62756-369-08)Marketed from Apr 1, 2022 | |
| 62756-369-18 | 62756036918 | 1000 TABLET in 1 BOTTLE (62756-369-18)Marketed from Apr 1, 2022 | |
| 62756-369-83 | 62756036983 | 30 TABLET in 1 BOTTLE (62756-369-83)Marketed from Apr 1, 2022 | |
| 62756-369-88 | 62756036988 | 100 TABLET in 1 BOTTLE (62756-369-88)Marketed from Apr 1, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 and Hydrochlorothiazide
- Generic name (nonproprietary)
- metoprolol tartrate and hydrochlorothiazide
- Active ingredients
- Metoprolol tartrate — 100 mg/1Hydrochlorothiazide — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090654
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 62756-369_99595af6-8c5d-4dc7-8396-e7bce050bb3fSPL ID 99595af6-8c5d-4dc7-8396-e7bce050bb3fSPL set ID faaf13ce-5d8d-4c57-a49f-a7a73daa41a5RxCUI 866479, 866482, 866491UNII W5S57Y3A5L, 0J48LPH2THUPC 0362756368880, 0362756369887, 0362756370883
- Pharmacologic class
- Thiazide Diuretic; 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
N462756036908followed by a unit qualifier and the quantityPackage 62756-0369-08. 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 and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090654
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 and Hydrochlorothiazide | Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 62756-368 |
| Metoprolol Tartrate and Hydrochlorothiazide | Metoprolol tartrate 50 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 62756-370 |