Prescription drug · ANDA
Doxazosin NDC 16571-166
Doxazosin mesylate 2 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-166-01 | 16571016601 | 100 TABLET in 1 BOTTLE (16571-166-01)Marketed from May 20, 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)
- Doxazosin
- Generic name (nonproprietary)
- doxazosin
- Active ingredients
- Doxazosin mesylate — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212727
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 16571-166_c7ae6273-26c7-4116-a42a-5c82e1b59849SPL ID c7ae6273-26c7-4116-a42a-5c82e1b59849SPL set ID 508b908e-8d80-422e-8ec0-2081185f4c95RxCUI 197625, 197626, 197627, 197628UNII 86P6PQK0MUUPC 0316571168019
- 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
N416571016601followed by a unit qualifier and the quantityPackage 16571-0166-01. 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)
Doxazosin tablets are an alpha 1 adrenergic antagonist indicated for: Signs and symptoms of Benign Prostatic Hyperplasia (BPH) Treatment of Hypertension 1.1 Benign Prostatic Hyperplasia (BPH) Doxazosin tablets are indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension Doxazosin tablets 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 b…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212727
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 |
|---|---|---|---|---|
| Doxazosin | Doxazosin mesylate 1 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-165 |
| Doxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-167 |
| Doxazosin | Doxazosin mesylate 8 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-168 |