Prescription drug · ANDA
Propranolol Hydrochloride NDC 0378-0183
Propranolol hydrochloride 20 mg/1 · Tablet · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-0183-01 | 00378018301 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0183-01)Marketed from Nov 19, 1985 | |
| 0378-0183-10 | 00378018310 | 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0183-10)Marketed from Nov 19, 1985 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070213
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 0378-0183_4b043e3b-c0dc-4e37-a2fb-86c51a99c054SPL ID 4b043e3b-c0dc-4e37-a2fb-86c51a99c054SPL set ID b94dcec7-7633-4a33-9cea-48161adeaf93RxCUI 856448, 856457, 856519, 856556, 856578UNII F8A3652H1VUPC 0303780187016, 0303780185012, 0303780184015, 0303780182011, 0303780183018
- 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
N400378018301followed by a unit qualifier and the quantityPackage 00378-0183-01. 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 tablets 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 tablets are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070213
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 10 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-235 |
| Propranolol Hydrochloride | Propranolol hydrochloride 80 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-238 |
| Propranolol Hydrochloride | Propranolol hydrochloride 20 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-236 |
| Propranolol Hydrochloride | Propranolol hydrochloride 40 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-237 |
| Propranolol Hydrochloride | Propranolol hydrochloride 60 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-239 |
| Propranolol Hydrochloride | Propranolol hydrochloride 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-961 |
| Propranolol Hydrochloride | Propranolol hydrochloride 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-339 |
| Propranolol Hydrochloride | Propranolol hydrochloride 10 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-0182 |
| Propranolol Hydrochloride | Propranolol hydrochloride 40 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-0184 |
| Propranolol Hydrochloride | Propranolol hydrochloride 80 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-0185 |
| Propranolol Hydrochloride | Propranolol hydrochloride 60 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-0187 |