Prescription drug · ANDA
Doxazosin NDC 71610-043
Doxazosin mesylate 4 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-043-60 | 7161000436071610004360 | 90 TABLET in 1 BOTTLE (71610-043-60)Marketed from Mar 2, 2018 |
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 — 4 mg/1
- Dosage form
- Tablet
- 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 075580
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 71610-043_98f8771c-b6c1-4fbe-845f-876cc3cbfe75SPL ID 98f8771c-b6c1-4fbe-845f-876cc3cbfe75SPL set ID 7e547752-a53a-4ad9-b70e-7cc2a1dd5d5dRxCUI 197627UNII 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
N471610004360followed by a unit qualifier and the quantityPackage 71610-0043-60. 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 A. Benign Prostatic Hyperplasia (BPH). Doxazosin Tablets, USP are indicated for the treatment of both the urinary outflow obstruction and obstructive and irritative symptoms associated with BPH: obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning). Doxazosin Tablets, USP may be used in all BPH patients whether hypertensive or normotensive. In patients with hypertension and BPH, both conditions were effectively treated with Doxazosin Tablets, USP monotherapy. Doxazosin Tablets, USP provide rapid improvement in symptoms and urinary flow r…
Excerpt only. Read the full label for complete information.
About NDC 71610-043
- What is NDC 71610-043?
- 71610-043 is the product NDC for Doxazosin, Doxazosin mesylate 4 mg/1 tablet, 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?
- Doxazosin.
- What is the active ingredient?
- Doxazosin mesylate.
- 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 Doxazosin?
- 106 other product NDCs are listed under this name. See all Doxazosin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Doxazosin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Doxazosin | Doxazosin mesylate 8 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-168 | 16571-0168-01 |
| Doxazosin | Doxazosin mesylate 1 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-165 | 16571-0165-01 |
| Doxazosin | Doxazosin mesylate 2 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-166 | 16571-0166-01 |
| Doxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-167 | 16571-0167-01 |
| Doxazosindoxazosin mesylate | Doxazosin mesylate 2 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-893 | 59651-0893-0159651-0893-99 |
| Doxazosindoxazosin mesylate | Doxazosin mesylate 1 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-892 | 59651-0892-0159651-0892-99 |
| Doxazosindoxazosin mesylate | Doxazosin mesylate 4 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-894 | 59651-0894-0159651-0894-99 |
| Doxazosindoxazosin mesylate | Doxazosin mesylate 8 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-895 | 59651-0895-0159651-0895-99 |
| Doxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4031 | 70518-4031-00 |
| Doxazosin | Doxazosin mesylate 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3965 | 70518-3965-0070518-3965-01 |
Other NDCs under ANDA 075580
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 | Major Pharmaceuticals | 0904-5522 |
| Doxazosin | Doxazosin mesylate 2 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5523 |
| Doxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5524 |
| Doxazosin | Doxazosin mesylate 2 mg/1 | TabletOral | AvKARE | 42291-258 |
| Doxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | AvKARE | 42291-259 |
| Doxazosin | Doxazosin mesylate 8 mg/1 | TabletOral | AvKARE | 42291-260 |
| Doxazosin | Doxazosin mesylate 2 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-739 |
| Doxazosin | Doxazosin mesylate 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-0701 |
| Doxazosin | Doxazosin mesylate 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-0704 |
| Doxazosin | Doxazosin mesylate 1 mg/1 | TabletOral | AvPAK | 50268-222 |
| Doxazosin | Doxazosin mesylate 2 mg/1 | TabletOral | AvPAK | 50268-223 |
| Doxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | AvPAK | 50268-224 |
| Doxazosin | Doxazosin mesylate 8 mg/1 | TabletOral | AvPAK | 50268-225 |
| Doxazosin | Doxazosin mesylate 1 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-476 |
| Doxazosin | Doxazosin mesylate 2 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-7996 |
| Doxazosin | Doxazosin mesylate 1 mg/1 | TabletOral | Apotex Corp. | 60505-0093 |
| Doxazosin | Doxazosin mesylate 2 mg/1 | TabletOral | Apotex Corp. | 60505-0094 |
| Doxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | Apotex Corp. | 60505-0095 |
| Doxazosin | Doxazosin mesylate 8 mg/1 | TabletOral | Apotex Corp. | 60505-0096 |
| Doxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3298 |
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