Prescription drug · ANDA
Propranolol Hydrochloride NDC 0054-3730
Propranolol hydrochloride 40 mg/5mL · Solution · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-3730-63 | 00054373063 | 500 mL in 1 BOTTLE, PLASTIC (0054-3730-63)Marketed from May 15, 1987 |
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)
- Propranolol Hydrochloride
- Generic name (nonproprietary)
- propranolol hydrochloride
- Active ingredients
- Propranolol hydrochloride — 40 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070690
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 0054-3730_f265c93a-a142-4ed0-8e1a-3f731aebe23cSPL ID f265c93a-a142-4ed0-8e1a-3f731aebe23cSPL set ID 8fe0a04c-bf5b-4ba0-9df6-58c27f24b52eRxCUI 856724, 856733UNII F8A3652H1VUPC 0300543730632, 0300543727632
- Pharmacologic class
- beta-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
N400054373063followed by a unit qualifier and the quantityPackage 00054-3730-63. 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 Hypertension Propranolol hydrochloride is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation Propranolol hydrochloride is indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction Propranolol hydrochloride is indicated …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070690
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 |
|---|---|---|---|---|
| Propranolol Hydrochloride | Propranolol hydrochloride 20 mg/5mL | SolutionOral | Hikma Pharmaceuticals USA Inc. | 0054-3727 |