Prescription drug · ANDA
Metoprolol Tartrate and Hydrochlorothiazide NDC 46708-115
Metoprolol tartrate 50 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-115-01 | 4670801150146708011501 | 1000 TABLET in 1 BOTTLE (46708-115-01)Marketed from Sep 17, 2013 | |
| 46708-115-10 | 4670801151046708011510 | 100 TABLET in 1 BOTTLE (46708-115-10)Marketed from Sep 17, 2013 | |
| 46708-115-30 | 4670801153046708011530 | 30 TABLET in 1 BOTTLE (46708-115-30)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 — 50 mg/1Hydrochlorothiazide — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- 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 46708-115_5afb35ed-f222-47c7-ac02-3b1d062b09d2SPL ID 5afb35ed-f222-47c7-ac02-3b1d062b09d2SPL set ID 538ea34a-1ac3-48c8-b841-43be09285e12RxCUI 866479, 866482, 866491UNII 0J48LPH2TH, W5S57Y3A5LUPC 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
N446708011501followed by a unit qualifier and the quantityPackage 46708-0115-01. 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)
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.
About NDC 46708-115
- What is NDC 46708-115?
- 46708-115 is the product NDC for Metoprolol Tartrate and Hydrochlorothiazide, Metoprolol tartrate 50 mg/1; Hydrochlorothiazide 25 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metoprolol Tartrate and Hydrochlorothiazide.
- What is the active ingredient?
- Metoprolol tartrate, Hydrochlorothiazide.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 and Hydrochlorothiazide?
- 13 other product NDCs are listed under this name. See all Metoprolol Tartrate and Hydrochlorothiazide 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 and Hydrochlorothiazide 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 Tartrate And Hydrochlorothiazide | Metoprolol tartrate 50 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-301 | 27241-0301-01 |
| Metoprolol Tartrate And Hydrochlorothiazide | Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-302 | 27241-0302-01 |
| Metoprolol Tartrate and Hydrochlorothiazide | Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 62756-368 | 62756-0368-0862756-0368-1862756-0368-83+1 more |
| Metoprolol Tartrate and Hydrochlorothiazide | Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 62756-369 | 62756-0369-0862756-0369-1862756-0369-83+1 more |
| Metoprolol Tartrate and Hydrochlorothiazide | Metoprolol tartrate 50 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 62756-370 | 62756-0370-0862756-0370-1862756-0370-83+1 more |
| Metoprolol Tartrate and Hydrochlorothiazide | Metoprolol tartrate 50 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-115 | 62332-0115-3062332-0115-3162332-0115-91 |
| Metoprolol Tartrate and Hydrochlorothiazide | Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-116 | 62332-0116-3062332-0116-3162332-0116-71 |
| Metoprolol Tartrate and Hydrochlorothiazide | Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-117 | 62332-0117-3062332-0117-3162332-0117-71 |
| Metoprolol Tartrate and Hydrochlorothiazide | Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-116 | 46708-0116-1046708-0116-3046708-0116-50 |
| Metoprolol Tartrate and Hydrochlorothiazide | Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-117 | 46708-0117-1046708-0117-3046708-0117-50 |
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 100 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-116 |
| Metoprolol Tartrate and Hydrochlorothiazide | Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-117 |
| 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 |