Prescription drug · ANDA
Nadolol NDC 68001-318
Nadolol 40 mg/1 · Tablet · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-318-00 | 68001031800 | 100 TABLET in 1 BOTTLE (68001-318-00)Marketed from Jan 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)
- Nadolol
- Generic name (nonproprietary)
- nadolol
- Active ingredients
- Nadolol — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- BluePoint LaboratoriesNDC labeler code 68001
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203455
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 68001-318_1980a55f-434f-5c45-e063-6394a90a014eSPL ID 1980a55f-434f-5c45-e063-6394a90a014eSPL set ID 0a2acdc0-aab6-462e-a377-67a0f3d55ec6RxCUI 198006, 198007, 198008UNII FEN504330VUPC 0368001319003, 0368001317009, 0368001318006
- 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
N468001031800followed by a unit qualifier and the quantityPackage 68001-0318-00. 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 are indicated for the long-term management of patients with angina pectoris. Hypertension Nadolol tablets, USP are 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. Control of high blood pressure should be part of comprehensive cardi…
Excerpt only. Read the full label for complete information.
About NDC 68001-318
- What is NDC 68001-318?
- 68001-318 is the product NDC for Nadolol, Nadolol 40 mg/1 tablet, listed with the FDA by BluePoint Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nadolol.
- What is the active ingredient?
- Nadolol.
- Who is the labeler?
- BluePoint Laboratories, NDC labeler code 68001. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nadolol?
- 52 other product NDCs are listed under this name. See all Nadolol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nadolol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nadolol | Nadolol 40 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4662 | 70518-4662-00 |
| Nadolol | Nadolol 40 mg/1 | TabletOral | BluePoint Laboratories | 68001-691 | 68001-0691-00 |
| Nadolol | Nadolol 20 mg/1 | TabletOral | BluePoint Laboratories | 68001-690 | 68001-0690-00 |
| Nadolol | Nadolol 80 mg/1 | TabletOral | BluePoint Laboratories | 68001-692 | 68001-0692-00 |
| Nadolol | Nadolol 20 mg/1 | TabletOral | American Health Packaging | 60687-887 | 60687-0887-21 |
| Nadolol | Nadolol 40 mg/1 | TabletOral | American Health Packaging | 60687-898 | 60687-0898-21 |
| Nadolol | Nadolol 20 mg/1 | TabletOral | BluePoint Laboratories | 68001-630 | 68001-0630-00 |
| Nadolol | Nadolol 40 mg/1 | TabletOral | BluePoint Laboratories | 68001-631 | 68001-0631-00 |
| Nadolol | Nadolol 80 mg/1 | TabletOral | BluePoint Laboratories | 68001-632 | 68001-0632-00 |
| Nadolol | Nadolol 20 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-402 | 46708-0402-3046708-0402-3146708-0402-91 |
Other NDCs under ANDA 203455
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 | BluePoint Laboratories | 68001-317 |
| Nadolol | Nadolol 20 mg/1 | TabletOral | American Health Packaging | 60687-302 |
| Nadolol | Nadolol 80 mg/1 | TabletOral | BluePoint Laboratories | 68001-319 |
| Nadolol | Nadolol 40 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-348 |
| Nadolol | Nadolol 20 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-347 |
| Nadolol | Nadolol 80 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-349 |
| Nadolol | Nadolol 40 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2233 |
| Nadolol | Nadolol 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2234 |
| Nadolol | Nadolol 20 mg/1 | TabletOral | Cipla USA Inc. | 69097-867 |
| Nadolol | Nadolol 40 mg/1 | TabletOral | Cipla USA Inc. | 69097-868 |
| Nadolol | Nadolol 80 mg/1 | TabletOral | Cipla USA Inc. | 69097-869 |