Prescription drug · NDA
Lotensin (Benazepril hydrochloride) NDC 30698-449
Benazepril hydrochloride 20 mg/1 · Tablet · Oral · Validus Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 30698-449-01 | 3069804490130698044901 | 100 TABLET in 1 BOTTLE (30698-449-01)Marketed from Jun 21, 1991 |
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)
- Lotensin
- Generic name (nonproprietary)
- benazepril hydrochloride
- Active ingredients
- Benazepril hydrochloride — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Validus Pharmaceuticals LLCNDC labeler code 30698
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019851
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 30698-449_40029d07-adfa-0cc3-e063-6294a90a4cd5SPL ID 40029d07-adfa-0cc3-e063-6294a90a4cd5SPL set ID 2abb091b-a53e-46b0-9b84-e5ee8f2bdd8eRxCUI 898687, 898689, 898690, 898692, 898719, 898721UNII N1SN99T69TUPC 0330698449011
- 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
N430698044901followed by a unit qualifier and the quantityPackage 30698-0449-01. 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)
1. INDICATIONS AND USAGE Lotensin ® is 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 on…
Excerpt only. Read the full label for complete information.
About NDC 30698-449
- What is NDC 30698-449?
- 30698-449 is the product NDC for Lotensin (benazepril hydrochloride), Benazepril hydrochloride 20 mg/1 tablet, listed with the FDA by Validus Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lotensin (Benazepril hydrochloride).
- What is the active ingredient?
- Benazepril hydrochloride.
- Who is the labeler?
- Validus Pharmaceuticals LLC, NDC labeler code 30698. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lotensin?
- 2 other product NDCs are listed under this name. See all Lotensin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lotensin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lotensinbenazepril hydrochloride | Benazepril hydrochloride 10 mg/1 | TabletOral | Validus Pharmaceuticals LLC | 30698-448 | 30698-0448-01 |
| Lotensinbenazepril hydrochloride | Benazepril hydrochloride 40 mg/1 | TabletOral | Validus Pharmaceuticals LLC | 30698-450 | 30698-0450-01 |
Other NDCs under NDA 019851
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 |
|---|---|---|---|---|
| Lotensinbenazepril hydrochloride | Benazepril hydrochloride 10 mg/1 | TabletOral | Validus Pharmaceuticals LLC | 30698-448 |
| Lotensinbenazepril hydrochloride | Benazepril hydrochloride 40 mg/1 | TabletOral | Validus Pharmaceuticals LLC | 30698-450 |