Prescription drug · ANDA
Metoprolol Tartrate and Hydrochlorothiazide NDC 46708-116
Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-116-10 | 46708011610 | 100 TABLET in 1 BOTTLE (46708-116-10)Marketed from Sep 17, 2013 | |
| 46708-116-30 | 46708011630 | 30 TABLET in 1 BOTTLE (46708-116-30)Marketed from Sep 17, 2013 | |
| 46708-116-50 | 46708011650 | 500 TABLET in 1 BOTTLE (46708-116-50)Marketed from Sep 17, 2013 |
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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202870
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 46708-116_5afb35ed-f222-47c7-ac02-3b1d062b09d2SPL ID 5afb35ed-f222-47c7-ac02-3b1d062b09d2SPL set ID 538ea34a-1ac3-48c8-b841-43be09285e12RxCUI 866479, 866482, 866491UNII W5S57Y3A5L, 0J48LPH2THUPC 0346708115302, 0346708116309, 0346708117306
- 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
N446708011610followed by a unit qualifier and the quantityPackage 46708-0116-10. 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)
INDICATIONS AND USAGE Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the management of hypertension This fixed-combination drug is not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202870
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 50 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-115 |
| Metoprolol Tartrate and Hydrochlorothiazide | Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-116 |
| Metoprolol Tartrate and Hydrochlorothiazide | Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-117 |
| Metoprolol Tartrate and Hydrochlorothiazide | Metoprolol tartrate 50 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-115 |
| Metoprolol Tartrate and Hydrochlorothiazide | Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-117 |