Prescription drug · ANDA
Doxazosin NDC 70518-3965
Doxazosin mesylate 2 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3965-0 | 70518396500 | 30 TABLET in 1 BLISTER PACK (70518-3965-0)Marketed from Dec 17, 2023 | |
| 70518-3965-1 | 70518396501 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-3965-1)Marketed from May 1, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208719
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 70518-3965_53fc8f29-09be-ba10-e063-6294a90af4bdSPL ID 53fc8f29-09be-ba10-e063-6294a90af4bdSPL set ID ec06f008-37a1-4757-a3ee-0b4720912bc4RxCUI 197626UNII 86P6PQK0MU
- 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
N470518396500followed by a unit qualifier and the quantityPackage 70518-3965-00. 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 alpha1 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 be…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208719
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 | Zydus Lifesciences Limited | 70771-1112 |
| Doxazosin | Doxazosin mesylate 2 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1113 |
| Doxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1114 |
| Doxazosin | Doxazosin mesylate 8 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1115 |
| Doxazosin | Doxazosin mesylate 8 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-831 |
| Doxazosin | Doxazosin mesylate 1 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-783 |
| Doxazosin | Doxazosin mesylate 2 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-784 |
| Doxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-785 |
| Doxazosin | Doxazosin mesylate 8 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-786 |
| Doxazosin | Doxazosin mesylate 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2395 |
| Doxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4892 |
| Doxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-3927 |
| Doxazosin | Doxazosin mesylate 2 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3811 |