Prescription drug · ANDA
Nadolol NDC 68382-733
Nadolol 40 mg/1 · Tablet · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-733-01 | 68382073301 | 100 TABLET in 1 BOTTLE (68382-733-01)Marketed from Aug 8, 2017 | |
| 68382-733-10 | 68382073310 | 1000 TABLET in 1 BOTTLE (68382-733-10)Marketed from Aug 8, 2017 | |
| 68382-733-16 | 68382073316 | 90 TABLET in 1 BOTTLE (68382-733-16)Marketed from Aug 8, 2017 | |
| 68382-733-77 | 68382073377 | 10 BLISTER PACK in 1 CARTON (68382-733-77) / 1 TABLET in 1 BLISTER PACK (68382-733-30)Marketed from Aug 8, 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
- Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207761
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 68382-733_d91f4594-496e-49f2-a187-ddd86f8634b4SPL ID d91f4594-496e-49f2-a187-ddd86f8634b4SPL set ID a0a38f9b-268d-4463-881d-5bee6cd92e8aRxCUI 198006, 198007, 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
N468382073301followed by a unit qualifier and the quantityPackage 68382-0733-01. 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 Angina Pectoris Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension Nadolol tablets 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 cardiovascular …
Excerpt only. Read the full label for complete information.
About NDC 68382-733
- What is NDC 68382-733?
- 68382-733 is the product NDC for Nadolol, Nadolol 40 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 4 package NDCs, 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?
- Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 207761
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 80 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0697 |
| Nadolol | Nadolol 40 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1090 |
| Nadolol | Nadolol 20 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1089 |
| Nadolol | Nadolol 80 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1091 |
| Nadolol | Nadolol 20 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-732 |
| Nadolol | Nadolol 80 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-734 |