Prescription drug · ANDA
Prazosin Hydrochloride NDC 51079-632
Prazosin hydrochloride 5 mg/1 · Capsule · Oral · Mylan Institutional Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51079-632-20 | 51079063220 | 100 BLISTER PACK in 1 CARTON (51079-632-20) / 1 CAPSULE in 1 BLISTER PACK (51079-632-01)Marketed from Oct 6, 1998 |
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)
- Prazosin Hydrochloride
- Generic name (nonproprietary)
- prazosin hydrochloride
- Active ingredients
- Prazosin hydrochloride — 5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Mylan Institutional Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072575
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 51079-632_3a874e40-912d-740d-e063-6394a90a4778SPL ID 3a874e40-912d-740d-e063-6394a90a4778SPL set ID e6a029b2-802f-4cc5-8795-20e177e8d779RxCUI 198141, 312593, 312594UNII X0Z7454B90
- Pharmacologic class
- alpha-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
N451079063220followed by a unit qualifier and the quantityPackage 51079-0632-20. 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 Prazosin hydrochloride 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 drug to achieve b…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 072575
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 |
|---|---|---|---|---|
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-1101 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1724 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Mylan Institutional Inc. | 51079-630 |
| Prazosin Hydrochloride | Prazosin hydrochloride 2 mg/1 | CapsuleOral | Mylan Institutional Inc. | 51079-631 |
| Prazosin Hydrochloride | Prazosin hydrochloride 2 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-2302 |
| Prazosin Hydrochloride | Prazosin hydrochloride 5 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-248 |
| Prazosin Hydrochloride | Prazosin hydrochloride 2 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-260 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 55289-536 |
| Prazosin Hydrochloride | Prazosin hydrochloride 5 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1443 |
| Prazosin Hydrochloride | Prazosin hydrochloride 5 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-3205 |
| Prazosin Hydrochloride | Prazosin hydrochloride 5 mg/1 | CapsuleOral | Safecor Health LLC | 48433-086 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Safecor Health LLC | 48433-084 |
| Prazosin Hydrochloride | Prazosin hydrochloride 2 mg/1 | CapsuleOral | Safecor Health LLC | 48433-085 |