Prescription drug · ANDA
Prazosin Hydrochloride NDC 71610-829
Prazosin hydrochloride 5 mg/1 · Capsule · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-829-27 | 7161008292771610082927 | 1250 CAPSULE in 1 BOTTLE (71610-829-27)Marketed from May 10, 2024 |
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
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214608
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 71610-829_18680839-460f-1189-e063-6394a90accdfSPL ID 18680839-460f-1189-e063-6394a90accdfSPL set ID 18680157-a123-1072-e063-6394a90ad5efRxCUI 198141UNII 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
N471610082927followed by a unit qualifier and the quantityPackage 71610-0829-27. 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, USP 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 achi…
Excerpt only. Read the full label for complete information.
About NDC 71610-829
- What is NDC 71610-829?
- 71610-829 is the product NDC for Prazosin Hydrochloride, Prazosin hydrochloride 5 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prazosin Hydrochloride.
- What is the active ingredient?
- Prazosin hydrochloride.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prazosin Hydrochloride?
- 104 other product NDCs are listed under this name. See all Prazosin Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prazosin Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| prazosin hydrochloride | Prazosin hydrochloride 5 mg/1 | CapsuleOral | Coupler LLC | 67046-1050 | 67046-1050-03 |
| prazosin hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4712 | 70518-4712-00 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-067 | 87441-0067-01 |
| Prazosin Hydrochloride | Prazosin hydrochloride 2 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-068 | 87441-0068-01 |
| Prazosin Hydrochloride | Prazosin hydrochloride 5 mg/1 | CapsuleOral | Coupler LLC | 67046-0781 | 67046-0781-03 |
| Prazosin Hydrochloride | Prazosin hydrochloride 5 mg/1 | CapsuleOral | Coupler LLC | 67046-1678 | 67046-1678-03 |
| Prazosin Hydrochloride | Prazosin hydrochloride 2 mg/1 | CapsuleOral | Coupler LLC | 67046-0504 | 67046-0504-03 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Coupler LLC | 67046-0680 | 67046-0680-03 |
| Prazosin Hydrochloride | Prazosin hydrochloride 2 mg/1 | CapsuleOral | Safecor Health LLC | 48433-085 | 48433-0085-20 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Safecor Health LLC | 48433-084 | 48433-0084-20 |
Other NDCs under ANDA 214608
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 | Granules Pharmaceuticals Inc. | 70010-084 |
| Prazosin Hydrochloride | Prazosin hydrochloride 2 mg/1 | CapsuleOral | Granules Pharmaceuticals Inc. | 70010-085 |
| Prazosin Hydrochloride | Prazosin hydrochloride 5 mg/1 | CapsuleOral | Granules Pharmaceuticals Inc. | 70010-086 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-693 |
| Prazosin Hydrochloride | Prazosin hydrochloride 2 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-694 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Exelan Pharmaceuticals | 76282-721 |
| Prazosin Hydrochloride | Prazosin hydrochloride 2 mg/1 | CapsuleOral | Exelan Pharmaceuticals | 76282-722 |
| Prazosin Hydrochloride | Prazosin hydrochloride 5 mg/1 | CapsuleOral | Exelan Pharmaceuticals | 76282-723 |