Prescription drug · NDA
Tezruly (terazosin) NDC 70954-592
Terazosin hydrochloride 1 mg/mL · Solution · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-592-10 | 70954059210 | 150 mL in 1 BOTTLE (70954-592-10)Marketed from Apr 18, 2025 |
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)
- Tezruly
- Generic name (nonproprietary)
- terazosin
- Active ingredients
- Terazosin hydrochloride — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218139
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 70954-592_0d2b0b80-5201-473a-9b43-f5c2127f6f7cSPL ID 0d2b0b80-5201-473a-9b43-f5c2127f6f7cSPL set ID 69582e0c-6569-490c-8c14-999f3750336fRxCUI 2689133, 2689139UNII D32S14F082UPC 0370954592105
- 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
N470954059210followed by a unit qualifier and the quantityPackage 70954-0592-10. 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)
TEZRULY TM (terazosin) is an alpha-1 adrenoceptor antagonist indicated for: The treatment of signs and symptoms of benign prostatic hyperplasia (BPH) (1.1) The treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction. (1.2) 1.1 Benign Prostatic Hyperplasia TEZRULY is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult males [see Clinical Studies (14.1)] . 1.2 Hypertension TEZRULY is indicated for the treatment of hypertension, to lower blood pressure in adults [see Clinical Stu…
Excerpt only. Read the full label for complete information.