Prescription drug · ANDA
Quinapril NDC 69097-842
Quinapril hydrochloride 20 mg/1 · Tablet · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-842-05 | 69097084205 | 90 TABLET in 1 BOTTLE (69097-842-05)Marketed from Jul 22, 2016 | |
| 69097-842-15 | 69097084215 | 1000 TABLET in 1 BOTTLE (69097-842-15)Marketed from Jul 22, 2016 |
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)
- Quinapril
- Generic name (nonproprietary)
- quinapril
- Active ingredients
- Quinapril hydrochloride — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078457
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 69097-842_56ce107f-65d9-4ec8-8859-6a256b27dc57SPL ID 56ce107f-65d9-4ec8-8859-6a256b27dc57SPL set ID e6d36e1e-8e35-4d06-83dc-45e0456365fdRxCUI 312748, 312749, 312750, 314203UNII 33067B3N2MUPC 0369097841058, 0369097839055, 0369097842055, 0369097843052
- 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
N469097084205followed by a unit qualifier and the quantityPackage 69097-0842-05. 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)
INDICATIONS AND USAGE Hypertension Quinapril 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. There are no controlled trials demonstrating risk reduction with quinapril. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking ce…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078457
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 |
|---|---|---|---|---|
| Quinapril | Quinapril hydrochloride 5 mg/1 | TabletOral | Cipla USA Inc. | 69097-839 |
| Quinapril | Quinapril hydrochloride 10 mg/1 | TabletOral | Cipla USA Inc. | 69097-841 |
| Quinapril | Quinapril hydrochloride 40 mg/1 | TabletOral | Cipla USA Inc. | 69097-843 |
| Quinapril | Quinapril hydrochloride 10 mg/1 | TabletOral | Proficient Rx LP | 63187-425 |