Prescription drug · ANDA
Terazosin (terazosin hydrochloride) NDC 71610-510
Terazosin hydrochloride 2 mg/1 · Capsule · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-510-30 | 71610051030 | 30 CAPSULE in 1 BOTTLE (71610-510-30)Marketed from Dec 29, 2020 | |
| 71610-510-53 | 71610051053 | 60 CAPSULE in 1 BOTTLE (71610-510-53)Marketed from Dec 29, 2020 | |
| 71610-510-60 | 71610051060 | 90 CAPSULE in 1 BOTTLE (71610-510-60)Marketed from Dec 29, 2020 | |
| 71610-510-70 | 71610051070 | 120 CAPSULE in 1 BOTTLE (71610-510-70)Marketed from Dec 29, 2020 | |
| 71610-510-80 | 71610051080 | 180 CAPSULE in 1 BOTTLE (71610-510-80)Marketed from Dec 29, 2020 | |
| 71610-510-92 | 71610051092 | 270 CAPSULE in 1 BOTTLE (71610-510-92)Marketed from Dec 29, 2020 | |
| 71610-510-94 | 71610051094 | 360 CAPSULE in 1 BOTTLE (71610-510-94)Marketed from Dec 29, 2020 |
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)
- Terazosin
- Generic name (nonproprietary)
- terazosin hydrochloride
- Active ingredients
- Terazosin hydrochloride — 2 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075317
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 71610-510_b23a32b3-7e6b-4b58-be96-303ac3ef069aSPL ID b23a32b3-7e6b-4b58-be96-303ac3ef069aSPL set ID 81d5422c-ff57-4f6d-927c-5de4dd7e1169RxCUI 313217, 313219UNII D32S14F082
- 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
N471610051030followed by a unit qualifier and the quantityPackage 71610-0510-30. 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 Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin capsules on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. Terazosin capsules can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075317
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 |
|---|---|---|---|---|
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 1 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0657 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 2 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2182 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2183 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 5 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-503 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 10 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-780 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 5 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-786 |
| Terazosin Hydrochloride | Terazosin hydrochloride 1 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-4525 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-5237 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 2 mg/1 | CapsuleOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-384 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 1 mg/1 | CapsuleOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-383 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 5 mg/1 | CapsuleOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-385 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 10 mg/1 | CapsuleOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-386 |
| Terazosin Hydrochloride | Terazosin hydrochloride 5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-1414 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 5 mg/1 | CapsuleOral | Proficient Rx LP | 63187-456 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 10 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-2371 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 10 mg/1 | CapsuleOral | AvPAK | 50268-767 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 1 mg/1 | CapsuleOral | AvPAK | 50268-764 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 2 mg/1 | CapsuleOral | AvPAK | 50268-765 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 5 mg/1 | CapsuleOral | AvPAK | 50268-766 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 5 mg/1 | CapsuleOral | Coupler LLC | 67046-1622 |
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