Prescription drug · ANDA
Nadolol NDC 70771-1091
Nadolol 80 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1091-0 | 70771109100 | 1000 TABLET in 1 BOTTLE (70771-1091-0)Marketed from Aug 8, 2017 | |
| 70771-1091-1 | 70771109101 | 100 TABLET in 1 BOTTLE (70771-1091-1)Marketed from Aug 8, 2017 | |
| 70771-1091-4 | 70771109104 | 10 BLISTER PACK in 1 CARTON (70771-1091-4) / 1 TABLET in 1 BLISTER PACK (70771-1091-2)Marketed from Aug 8, 2017 | |
| 70771-1091-9 | 70771109109 | 90 TABLET in 1 BOTTLE (70771-1091-9)Marketed from Aug 8, 2017 |
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
- Zydus Lifesciences LimitedNDC labeler code 70771
- 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 70771-1091_af4aa709-b3ff-49c4-91d5-353a99d46696SPL ID af4aa709-b3ff-49c4-91d5-353a99d46696SPL set ID 29433c5a-51c6-4fb9-9174-1b1c616c9e57RxCUI 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
N470771109100followed by a unit qualifier and the quantityPackage 70771-1091-00. 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 .
About NDC 70771-1091
- What is NDC 70771-1091?
- 70771-1091 is the product NDC for Nadolol, Nadolol 80 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. 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 Lifesciences Limited, NDC labeler code 70771. 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 20 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-732 |
| Nadolol | Nadolol 40 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-733 |
| Nadolol | Nadolol 80 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-734 |