Prescription drug · ANDA
Benazepril Hydrochloride NDC 53746-752
Benazepril hydrochloride 10 mg/1 · Tablet · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53746-752-01 | 53746075201 | 100 TABLET in 1 BOTTLE (53746-752-01)Marketed from Sep 26, 2022 | |
| 53746-752-05 | 53746075205 | 500 TABLET in 1 BOTTLE (53746-752-05)Marketed from Sep 26, 2022 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals of New York LLCNDC labeler code 53746
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076820
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 53746-752_e6ad086e-a030-4d1c-ad5c-6e7568f37439SPL ID e6ad086e-a030-4d1c-ad5c-6e7568f37439SPL set ID e0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9eRxCUI 898687, 898690, 898719, 898723UNII N1SN99T69TUPC 0353746751010, 0353746754011, 0353746753014, 0353746752017
- 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
N453746075201followed by a unit qualifier and the quantityPackage 53746-0752-01. 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 . 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 53746-752
- What is NDC 53746-752?
- 53746-752 is the product NDC for Benazepril Hydrochloride, Benazepril hydrochloride 10 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 2 package NDCs, 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?
- Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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 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 40 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-527 | 62559-0527-0162559-0527-05 |
| 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 076820
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 | TabletOral | Proficient Rx LP | 71205-244 |
| Benazepril Hydrochloride | Benazepril hydrochloride 5 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-751 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-753 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-754 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0854 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1816 |
| Benazepril Hydrochloride | Benazepril hydrochloride 5 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-751 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-752 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-753 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-754 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4343 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4344 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1086 |
| Benazepril Hydrochloride | Benazepril hydrochloride 5 mg/1 | TabletOral | AvPAK | 50268-109 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | TabletOral | AvPAK | 50268-110 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | TabletOral | AvPAK | 50268-111 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | TabletOral | AvPAK | 50268-112 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-755 |