Prescription drug · ANDA
Nebivolol NDC 70518-3527
Nebivolol hydrochloride 5 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3527-0 | 7051835270070518352700 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-3527-0)Marketed from Sep 20, 2022 |
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)
- Nebivolol
- Generic name (nonproprietary)
- nebivolol
- Active ingredients
- Nebivolol hydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203828
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 70518-3527_48be4213-e2e2-10b7-e063-6294a90aee17SPL ID 48be4213-e2e2-10b7-e063-6294a90aee17SPL set ID 3745fc9d-cd3f-4877-bef0-81d9a9a05786RxCUI 387013UNII JGS34J7L9I
- 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
N470518352700followed by a unit qualifier and the quantityPackage 70518-3527-00. 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 .
Indications (excerpt from the label)
Nebivolol is a beta-adrenergic blocking agent 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. ( 1.1 ) 1.1 Hypertension Nebivolol tablets are indicated for the treatment of hypertension, to lower blood pressure [ see Clinical Studies ( 14.1 )]. Nebivolol tablets may be used alone or in combination with other antihypertensive agents [ see Drug Interactions ( 7 )]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trial…
Excerpt only. Read the full label for complete information.
About NDC 70518-3527
- What is NDC 70518-3527?
- 70518-3527 is the product NDC for Nebivolol, Nebivolol hydrochloride 5 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nebivolol.
- What is the active ingredient?
- Nebivolol hydrochloride.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nebivolol?
- 89 other product NDCs are listed under this name. See all Nebivolol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nebivolol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nebivolol | Nebivolol 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7500 | 00904-7500-04 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4648 | 70518-4648-00 |
| Nebivolol | Nebivolol hydrochloride 2.5 mg/1 | TabletOral | NorthStar RxLLC | 72603-870 | 72603-0870-01 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | NorthStar RxLLC | 72603-871 | 72603-0871-0172603-0871-02 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | NorthStar RxLLC | 72603-872 | 72603-0872-0172603-0872-02 |
| Nebivolol | Nebivolol hydrochloride 20 mg/1 | TabletOral | NorthStar RxLLC | 72603-873 | 72603-0873-0172603-0873-02 |
| Nebivolol | Nebivolol 2.5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7497 | 00904-7497-04 |
| Nebivolol | Nebivolol 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7498 | 00904-7498-04 |
| Nebivolol | Nebivolol 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7499 | 00904-7499-04 |
| Nebivolol | Nebivolol hydrochloride 2.5 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-457 | 33342-0457-0733342-0457-1033342-0457-25 |
Other NDCs under ANDA 203828
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 |
|---|---|---|---|---|
| Nebivolol | Nebivolol hydrochloride 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5708 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5752 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-5761 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | American Health Packaging | 60687-641 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | American Health Packaging | 60687-652 |
| Nebivolol | Nebivolol hydrochloride 20 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-390 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-391 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-392 |
| Nebivolol | Nebivolol hydrochloride 2.5 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-393 |