Prescription drug · ANDA
Phentolamine Mesylate NDC 0143-9564
Phentolamine mesylate 5 mg/mL · Injection, Powder, For solution · Intramuscular, Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9564-01 | 00143956401 | 1 VIAL in 1 BOX (0143-9564-01) / 1 mL in 1 VIALMarketed from Nov 4, 2015 | |
| 0143-9564-10 | 00143956410 | 10 VIAL in 1 BOX (0143-9564-10) / 1 mL in 1 VIALMarketed from Nov 4, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Phentolamine Mesylate
- Generic name (nonproprietary)
- phentolamine mesylate
- Active ingredients
- Phentolamine mesylate — 5 mg/mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular, Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040235
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 0143-9564_264ee71e-7e33-4693-b993-8ee0cc2f8d48SPL ID 264ee71e-7e33-4693-b993-8ee0cc2f8d48SPL set ID ed6c506c-5535-4b7c-ae1a-d63f09d796c9RxCUI 1361023UNII Y7543E5K9T
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400143956401followed by a unit qualifier and the quantityPackage 00143-9564-01. 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 Phentolamine Mesylate for Injection is indicated for the prevention or control of hypertensive episodes that may occur in a patient with pheochromocytoma as a result of stress or manipulation during preoperative preparation and surgical excision. Phentolamine Mesylate for Injection is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine. Phentolamine Mesylate for Injection is also indicated for the diagnosis of pheochromocytoma by the phentolamine blocking test.
Excerpt only. Read the full label for complete information.