Prescription drug · ANDA
Benazepril Hydrochloride NDC 43063-748
Benazepril hydrochloride 40 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-748-30 | 43063074830 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-748-30)Marketed from Feb 24, 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)
- Benazepril Hydrochloride
- Generic name (nonproprietary)
- benazepril hydrochloride
- Active ingredients
- Benazepril hydrochloride — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078212
- Marketing start
- Marketing end
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 43063-748_51cc6ee4-27b7-62c2-e063-6294a90ada01SPL ID 51cc6ee4-27b7-62c2-e063-6294a90ada01SPL set ID 5de2ea54-877d-46e9-b4c2-bf1ab9d0f19cRxCUI 898719UNII N1SN99T69TUPC 0343063748305
- Pharmacologic class
- Angiotensin Converting Enzyme Inhibitor
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
N443063074830followed by a unit qualifier and the quantityPackage 43063-0748-30. 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)
Benazepril hydrochloride 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. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one …
Excerpt only. Read the full label for complete information.
About NDC 43063-748
- What is NDC 43063-748?
- 43063-748 is the product NDC for Benazepril Hydrochloride, Benazepril hydrochloride 40 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Benazepril Hydrochloride.
- What is the active ingredient?
- Benazepril hydrochloride.
- Who is the labeler?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Benazepril Hydrochloride?
- 84 other product NDCs are listed under this name. See all Benazepril Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Benazepril Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-527 | 62559-0527-0162559-0527-05 |
| Benazepril Hydrochloride | Benazepril hydrochloride 5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-524 | 62559-0524-0162559-0524-05 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-525 | 62559-0525-0162559-0525-05 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-526 | 62559-0526-0162559-0526-05 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4633 | 70518-4633-00 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-100 | 84386-0100-0184386-0100-90 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-101 | 84386-0101-0184386-0101-90 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-102 | 84386-0102-0184386-0102-90 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | Tablet, CoatedOral | Northwind Health Company, LLC | 82868-089 | 82868-0089-30 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8877 | 68788-8877-0168788-8877-0368788-8877-06+1 more |
Other NDCs under ANDA 078212
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 |
|---|---|---|---|---|
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-388 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-117 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-118 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5028 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1365 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-100 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-320 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-101 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-102 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5750 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5751 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3359 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4722 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-617 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8877 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-202 |