Prescription drug · ANDA
Metoprolol Tartrate and Hydrochlorothiazide NDC 0378-0424
Metoprolol tartrate 50 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-0424-01 | 0037804240100378042401 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0424-01)Marketed from Aug 20, 2004 |
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 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
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076792
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 0378-0424_2631c7b0-5af8-4967-b945-d3398b2147baSPL ID 2631c7b0-5af8-4967-b945-d3398b2147ba
- 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
N400378042401followed by a unit qualifier and the quantityPackage 00378-0424-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0378-0424
- What is NDC 0378-0424?
- 0378-0424 is the product NDC for Metoprolol Tartrate and Hydrochlorothiazide, Metoprolol tartrate 50 mg/1; Hydrochlorothiazide 25 mg/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, 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?
- 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 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 50 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-115 | 46708-0115-0146708-0115-1046708-0115-30 |
| 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 |
Other NDCs under ANDA 076792
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 | Mylan Pharmaceuticals Inc. | 0378-0434 |
| Metoprolol Tartrate and Hydrochlorothiazide | Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 50 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-0445 |