Prescription drug · ANDA
Verapamil Hydrochloride NDC 0378-6440
Verapamil hydrochloride 240 mg/1 · Capsule, Extended release · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-6440-01 | 00378644001 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6440-01)Marketed from May 20, 1999 |
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)
- Verapamil Hydrochloride
- Generic name (nonproprietary)
- verapamil hydrochloride
- Active ingredients
- Verapamil hydrochloride — 240 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075138
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 0378-6440_c63ca9bc-5c77-4e53-8adf-9cfd16bfe012SPL ID c63ca9bc-5c77-4e53-8adf-9cfd16bfe012SPL set ID c86084bc-33aa-eece-5a96-6c0dad2d1a32RxCUI 897612, 897618, 897624UNII V3888OEY5RUPC 0303786380015, 0303786320011, 0303786440016
- Pharmacologic class
- Calcium Channel 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
N400378644001followed by a unit qualifier and the quantityPackage 00378-6440-01. 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 Verapamil hydrochloride extended-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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 this drug. 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 one …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075138
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 |
|---|---|---|---|---|
| Verapamil Hydrochloride | Verapamil hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-6320 |
| Verapamil Hydrochloride | Verapamil hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-6380 |
| Verapamil Hydrochloride | Verapamil hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Safecor Health LLC | 48433-145 |
| Verapamil Hydrochloride | Verapamil hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Mylan Institutional Inc. | 51079-917 |