Prescription drug · ANDA
Propranolol Hydrochloride NDC 0228-2778
Propranolol hydrochloride 60 mg/1 · Capsule, Extended release · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0228-2778-11 | 00228277811 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2778-11)Marketed from Aug 10, 2007 |
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 — 60 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078494
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 0228-2778_1f70f68b-1314-4c20-872e-993e0f33fb43SPL ID 1f70f68b-1314-4c20-872e-993e0f33fb43SPL set ID a4edba76-29b8-41fb-bf0b-d4633abba003RxCUI 856460, 856481, 856535, 856569UNII F8A3652H1VUPC 0302282780114
- 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
N400228277811followed by a unit qualifier and the quantityPackage 00228-2778-11. 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 are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride extended-release capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine Propranolol hydrochloride extended-release capsules are indicated for the prophylaxis of common migraine headache. …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078494
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 160 mg/1 | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0228-2781 |
| Propranolol Hydrochloride | Propranolol hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Proficient Rx LP | 71205-760 |
| Propranolol Hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Proficient Rx LP | 71205-761 |
| Propranolol Hydrochloride | Propranolol hydrochloride 80 mg/1 | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0228-2779 |
| Propranolol Hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0228-2780 |