Prescription drug · ANDA
terazosin NDC 71335-9607
Terazosin hydrochloride 10 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-9607-1 | 71335960701 | 30 CAPSULE in 1 BOTTLE (71335-9607-1)Marketed from Dec 20, 2022 | |
| 71335-9607-2 | 71335960702 | 28 CAPSULE in 1 BOTTLE (71335-9607-2)Marketed from Dec 20, 2022 | |
| 71335-9607-3 | 71335960703 | 90 CAPSULE in 1 BOTTLE (71335-9607-3)Marketed from Dec 20, 2022 |
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)
- terazosin
- Generic name (nonproprietary)
- terazosin
- Active ingredients
- Terazosin hydrochloride — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075614
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 71335-9607_ff1d7383-5600-487f-b66e-4c2eef397eafSPL ID ff1d7383-5600-487f-b66e-4c2eef397eafSPL set ID 2cdbb03d-0ac9-477b-88f6-5d9492277048RxCUI 260376UNII 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
N471335960701followed by a unit qualifier and the quantityPackage 71335-9607-01. 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)
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. The long term effects of terazosin 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. They 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 075614
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 |
|---|---|---|---|---|
| terazosin | Terazosin hydrochloride 1 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-022 |
| terazosin | Terazosin hydrochloride 2 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-915 |
| terazosin | Terazosin hydrochloride 1 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7851 |
| Terazosin | Terazosin hydrochloride 1 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-458 |
| Terazosin | Terazosin hydrochloride 2 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-459 |
| Terazosin | Terazosin hydrochloride 5 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-460 |
| Terazosin | Terazosin hydrochloride 10 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-461 |
| terazosin | Terazosin hydrochloride 2 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-736 |
| terazosin | Terazosin hydrochloride 1 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-735 |
| terazosin | Terazosin hydrochloride 5 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-737 |
| terazosin | Terazosin hydrochloride 10 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-738 |
| terazosin | Terazosin hydrochloride 1 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3193 |
| terazosin | Terazosin hydrochloride 2 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8171 |