Prescription drug · ANDA
Terazosin NDC 69452-332
Terazosin hydrochloride 5 mg/1 · Capsule · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-332-20 | 6945203322069452033220 | 100 CAPSULE in 1 BOTTLE (69452-332-20)Marketed from Mar 11, 2024 | |
| 69452-332-32 | 6945203323269452033232 | 1000 CAPSULE in 1 BOTTLE (69452-332-32)Marketed from Dec 20, 2024 |
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
- Active ingredients
- Terazosin hydrochloride — 5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bionpharma Inc.NDC labeler code 69452
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075667
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 69452-332_29b9921b-6884-e5bb-e063-6394a90aecf6SPL ID 29b9921b-6884-e5bb-e063-6394a90aecf6SPL set ID 130c84dc-b598-660f-e063-6294a90a8e46RxCUI 260376, 313215, 313217, 313219UNII D32S14F082UPC 0369452331323, 0369452330326, 0369452333327, 0369452332320
- 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
N469452033220followed by a unit qualifier and the quantityPackage 69452-0332-20. 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 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. It 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.
About NDC 69452-332
- What is NDC 69452-332?
- 69452-332 is the product NDC for Terazosin, Terazosin hydrochloride 5 mg/1 capsule, listed with the FDA by Bionpharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Terazosin.
- What is the active ingredient?
- Terazosin hydrochloride.
- Who is the labeler?
- Bionpharma Inc., NDC labeler code 69452. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Terazosin?
- 61 other product NDCs are listed under this name. See all Terazosin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Terazosin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Terazosin | Terazosin hydrochloride 2 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4064 | 68788-4064-0168788-4064-03 |
| Terazosin | Terazosin hydrochloride 2 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4545 | 70518-4545-00 |
| Terazosinterazosin hydrochloride | Terazosin hydrochloride 5 mg/1 | CapsuleOral | Coupler LLC | 67046-1622 | 67046-1622-03 |
| Terazosin | Terazosin hydrochloride 1 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-288 | 27241-0288-0127241-0288-10 |
| Terazosin | Terazosin hydrochloride 2 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-289 | 27241-0289-0127241-0289-10 |
| Terazosin | Terazosin hydrochloride 5 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-290 | 27241-0290-0127241-0290-10 |
| Terazosin | Terazosin hydrochloride 10 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-291 | 27241-0291-0127241-0291-10 |
| Terazosin | Terazosin hydrochloride 1 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-330 | 69452-0330-2069452-0330-32 |
| Terazosin | Terazosin hydrochloride 2 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-331 | 69452-0331-2069452-0331-32 |
| Terazosin | Terazosin hydrochloride 10 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-333 | 69452-0333-2069452-0333-32 |
Other NDCs under ANDA 075667
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 2 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4064 |
| Terazosin | Terazosin hydrochloride 1 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-330 |
| Terazosin | Terazosin hydrochloride 2 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-331 |
| Terazosin | Terazosin hydrochloride 10 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-333 |
| Terazosin | Terazosin hydrochloride 2 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4545 |
| Terazosin | Terazosin hydrochloride 2 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3059 |
| Terazosin | Terazosin hydrochloride 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3123 |
| Terazosin | Terazosin hydrochloride 5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3131 |