Prescription drug · NDA AUTHORIZED GENERIC
Propranolol Hydrochloride ER (propranolol hydrochloride) NDC 62559-531
Propranolol hydrochloride 80 mg/1 · Capsule, Extended release · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-531-01 | 62559053101 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-531-01)Marketed from Dec 21, 2017 |
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)
- Propranolol Hydrochloride ERSuffix: ER
- Generic name (nonproprietary)
- propranolol hydrochloride
- Active ingredients
- Propranolol hydrochloride — 80 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 018553
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 62559-531_d8d19d03-6204-496a-9a53-9842a802653cSPL ID d8d19d03-6204-496a-9a53-9842a802653cSPL set ID 5415904b-90da-48e8-9f9e-f86749aa129cRxCUI 856460, 856481, 856535, 856569UNII F8A3652H1VUPC 0362559531016, 0362559533010, 0362559532013, 0362559530019
- 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
N462559053101followed by a unit qualifier and the quantityPackage 62559-0531-01. 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 Hypertension Propranolol hydrochloride extended-release capsules USP are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules USP are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride extended-release capsules USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine Propranolol hydrochloride extended-release capsules USP are indicated for the prophylaxis of common m…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 018553
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 |
|---|---|---|---|---|
| Inderal LApropranolol hydrochloride | Propranolol hydrochloride 60 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-520 |
| Inderal LApropranolol hydrochloride | Propranolol hydrochloride 80 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-521 |
| Inderal LApropranolol hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-522 |
| Inderal LApropranolol hydrochloride | Propranolol hydrochloride 160 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-523 |
| Propranolol Hydrochloride ERpropranolol hydrochloride | Propranolol hydrochloride 60 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-530 |
| Propranolol Hydrochloride ERpropranolol hydrochloride | Propranolol hydrochloride 160 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-533 |
| Propranolol Hydrochloride ERpropranolol hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-532 |