Prescription drug · ANDA
Nadolol NDC 72162-2198
Nadolol 80 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2198-1 | 72162219801 | 100 TABLET in 1 BOTTLE (72162-2198-1)Marketed from Jul 26, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Nadolol
- Generic name (nonproprietary)
- nadolol
- Active ingredients
- Nadolol — 80 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210955
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 72162-2198_6f88375c-2876-4313-900f-b6ab8a582ca2SPL ID 6f88375c-2876-4313-900f-b6ab8a582ca2SPL set ID 2d126308-c58d-4950-9dcb-eaadb1a2054fRxCUI 198008UNII FEN504330V
- 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
N472162219801followed by a unit qualifier and the quantityPackage 72162-2198-01. 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 Angina Pectoris Nadolol tablets, USP is indicated for the long-term management of patients with angina pectoris. Hypertension Nadolol tablets, USP is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Nadolol tablets, USP. Control of high blood pressure should be part of comprehe…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210955
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 |
|---|---|---|---|---|
| Nadolol | Nadolol 20 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-977 |
| Nadolol | Nadolol 40 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-978 |
| Nadolol | Nadolol 80 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-979 |
| Nadolol | Nadolol 20 mg/1 | TabletOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-133 |
| Nadolol | Nadolol 40 mg/1 | TabletOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-134 |
| Nadolol | Nadolol 80 mg/1 | TabletOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-135 |
| Nadolol | Nadolol 20 mg/1 | TabletOral | American Health Packaging | 60687-887 |
| Nadolol | Nadolol 40 mg/1 | TabletOral | American Health Packaging | 60687-898 |
| Nadolol | Nadolol 80 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2131 |
| Nadolol | Nadolol 20 mg/1 | TabletOral | BluePoint Laboratories | 68001-630 |
| Nadolol | Nadolol 40 mg/1 | TabletOral | BluePoint Laboratories | 68001-631 |
| Nadolol | Nadolol 80 mg/1 | TabletOral | BluePoint Laboratories | 68001-632 |