Prescription drug · ANDA
Benazepril Hydrochloride NDC 43547-338
Benazepril hydrochloride 40 mg/1 · Tablet, Coated · Oral · Solco healthcare U.S., LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-338-03 | 43547033803 | 30 TABLET, COATED in 1 BOTTLE (43547-338-03)Marketed from Jun 30, 2019 | |
| 43547-338-10 | 43547033810 | 100 TABLET, COATED in 1 BOTTLE (43547-338-10)Marketed from Jan 1, 2014 | |
| 43547-338-50 | 43547033850 | 500 TABLET, COATED in 1 BOTTLE (43547-338-50)Marketed from Jan 1, 2014 |
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, Coated
- Route
- Oral
- Labeler
- Solco healthcare U.S., LLCNDC labeler code 43547
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076118
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 43547-338_fc8f15d2-3382-4933-a6bb-b1c57d50d57bSPL ID fc8f15d2-3382-4933-a6bb-b1c57d50d57bSPL set ID bb91223e-ffa5-4a3a-b191-fe121250c20cRxCUI 898687, 898690, 898719, 898723UNII N1SN99T69TUPC 0343547338039, 0343547336103, 0343547336035, 0343547335038, 0343547337032
- 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
N443547033803followed by a unit qualifier and the quantityPackage 43547-0338-03. 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 43547-338
- What is NDC 43547-338?
- 43547-338 is the product NDC for Benazepril Hydrochloride, Benazepril hydrochloride 40 mg/1 tablet, coated, listed with the FDA by Solco healthcare U.S., LLC. It has 3 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?
- Solco healthcare U.S., LLC, NDC labeler code 43547. 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 076118
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 10 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals, Inc. | 68788-9327 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals, Inc. | 68788-9313 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-0078 |
| Benazepril Hydrochloride | Benazepril hydrochloride 5 mg/1 | Tablet, CoatedOral | Solco healthcare U.S., LLC | 43547-335 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-3775 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | Tablet, CoatedOral | Solco healthcare U.S., LLC | 43547-336 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | Tablet, CoatedOral | Solco healthcare U.S., LLC | 43547-337 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 63187-499 |
| Benazepril Hydrochloride | Benazepril hydrochloride 5 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 63187-500 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | Tablet, CoatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-677 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | Tablet, CoatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-679 |
| Benazepril Hydrochloride | Benazepril hydrochloride 5 mg/1 | Tablet, CoatedOral | Golden State Medical Supply, Inc. | 51407-462 |
| Benazepril Hydrochloride | Benazepril hydrochloride 10 mg/1 | Tablet, CoatedOral | Golden State Medical Supply, Inc. | 51407-463 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | Tablet, CoatedOral | Golden State Medical Supply, Inc. | 51407-464 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | Tablet, CoatedOral | Golden State Medical Supply, Inc. | 51407-465 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 63187-906 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-0267 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals,Inc. | 68071-1769 |
| Benazepril Hydrochloride | Benazepril hydrochloride 40 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals,Inc. | 68071-1770 |
| Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals,Inc. | 68071-1969 |
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