Prescription drug · NDA
Inderal LA (propranolol hydrochloride) NDC 62559-521
Propranolol hydrochloride 80 mg/1 · Capsule, Extended release · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-521-01 | 62559052101 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-521-01)Marketed from Apr 28, 2017 | |
| 62559-521-30 | 62559052130 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-521-30)Marketed from Aug 5, 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)
- Inderal LASuffix: LA
- 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 — New Drug ApplicationApplication NDA 018553
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 62559-521_fd4ca726-c6f1-4fe6-b4b7-63a13f4944f7SPL ID fd4ca726-c6f1-4fe6-b4b7-63a13f4944f7SPL set ID 35d28979-36b1-4630-b85e-a44e0a443734RxCUI 856460, 856462, 856481, 856483, 856535, 856537, 856569, 856571UNII F8A3652H1VUPC 0362559521017, 0362559523011, 0362559522014, 0362559520010
- 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
N462559052101followed by a unit qualifier and the quantityPackage 62559-0521-01. 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 Inderal LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal LA is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Inderal LA is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine Inderal LA is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Hypertrophic…
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 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 80 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-531 |
| Propranolol Hydrochloride ERpropranolol hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-532 |