Prescription drug · ANDA
Phenoxybenzamine Hydrochloride NDC 35573-473
Phenoxybenzamine hydrochloride 10 mg/1 · Capsule · Oral · Burel Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35573-473-02 | 35573047302 | 100 CAPSULE in 1 BOTTLE (35573-473-02)Marketed from May 8, 2023 |
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)
- Phenoxybenzamine Hydrochloride
- Generic name (nonproprietary)
- phenoxybenzamine hydrochloride
- Active ingredients
- Phenoxybenzamine hydrochloride — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Burel Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215600
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 35573-473_609aa41e-4cb5-4cdf-9137-f429c21b4fabSPL ID 609aa41e-4cb5-4cdf-9137-f429c21b4fabSPL set ID 609aa41e-4cb5-4cdf-9137-f429c21b4fabRxCUI 861402UNII X1IEG24OHL
- 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
N435573047302followed by a unit qualifier and the quantityPackage 35573-0473-02. 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)
INDICATION AND USAGE Phenoxybenzamine hydrochloride capsules are indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating. If tachycardia is excessive, it may be necessary to use a beta -blocking agent concomitantly.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215600
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 |
|---|---|---|---|---|
| Phenoxybenzamine Hydrochloride | Phenoxybenzamine hydrochloride 10 mg/1 | CapsuleOral | NorthStar Rx LLC | 72603-229 |
| Phenoxybenzamine Hydrochloride | Phenoxybenzamine hydrochloride 10 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-327 |