Prescription drug · ANDA
propranolol hydrochloride NDC 42291-523
Propranolol hydrochloride 80 mg/1 · Capsule, Extended release · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-523-01 | 42291052301 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-523-01)Marketed from May 16, 2017 | |
| 42291-523-10 | 42291052310 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-523-10)Marketed from Jul 31, 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
- Generic name (nonproprietary)
- propranolol hydrochloride
- Active ingredients
- Propranolol hydrochloride — 80 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078703
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 42291-523_4b93e61b-2f17-4421-e063-6394a90ae3f3SPL ID 4b93e61b-2f17-4421-e063-6394a90ae3f3SPL set ID 753ab3cb-e7ee-424b-aa7d-195b5871a40eRxCUI 856460, 856481, 856535, 856569UNII F8A3652H1V
- 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
N442291052301followed by a unit qualifier and the quantityPackage 42291-0523-01. 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 . This label includes a boxed warning.
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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078703
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 60 mg/1 | Capsule, Extended releaseOral | Breckenridge Pharmaceutical, Inc. | 51991-817 |
| propranolol hydrochloride | Propranolol hydrochloride 160 mg/1 | Capsule, Extended releaseOral | Breckenridge Pharmaceutical, Inc. | 51991-820 |
| propranolol hydrochloride | Propranolol hydrochloride 80 mg/1 | Capsule, Extended releaseOral | Breckenridge Pharmaceutical, Inc. | 51991-818 |
| propranolol hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Breckenridge Pharmaceutical, Inc. | 51991-819 |
| Propranolol Hydrochloride | Propranolol hydrochloride 60 mg/1 | Capsule, Extended releaseOral | American Health Packaging | 60687-215 |
| Propranolol Hydrochloride | Propranolol hydrochloride 80 mg/1 | Capsule, Extended releaseOral | American Health Packaging | 60687-226 |
| propranolol hydrochloride | Propranolol hydrochloride 60 mg/1 | Capsule, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-867 |
| propranolol hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-524 |
| propranolol hydrochloride | Propranolol hydrochloride 60 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-522 |
| propranolol hydrochloride | Propranolol hydrochloride 160 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-525 |
| propranolol hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-1463 |
| propranolol hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-037 |
| propranolol hydrochloride | Propranolol hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-035 |
| propranolol hydrochloride | Propranolol hydrochloride 80 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-036 |
| propranolol hydrochloride | Propranolol hydrochloride 160 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-038 |
| propranolol hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 72162-1604 |
| propranolol hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-9282 |
| propranolol hydrochloride | Propranolol hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 72162-1602 |
| propranolol hydrochloride | Propranolol hydrochloride 160 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 72162-1605 |
| propranolol hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2781 |
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