Prescription drug · ANDA
Quinapril NDC 43547-411
Quinapril hydrochloride 10 mg/1 · Tablet · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-411-09 | 43547041109 | 90 TABLET in 1 BOTTLE (43547-411-09)Marketed from Nov 10, 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)
- Quinapril
- Generic name (nonproprietary)
- quinapril
- Active ingredients
- Quinapril hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solco Healthcare US, LLCNDC labeler code 43547
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205823
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 43547-411_b8f1731a-cbac-4f64-a8d4-320b80b335e1SPL ID b8f1731a-cbac-4f64-a8d4-320b80b335e1SPL set ID cd46691d-5593-4a9f-a937-999c6803e312RxCUI 312748, 312749, 312750, 314203UNII 33067B3N2M
- 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
N443547041109followed by a unit qualifier and the quantityPackage 43547-0411-09. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Hypertension Quinapril 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. There are no controlled trials demonstrating risk reduction with quinapril tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic th…
Excerpt only. Read the full label for complete information.
About NDC 43547-411
- What is NDC 43547-411?
- 43547-411 is the product NDC for Quinapril, Quinapril hydrochloride 10 mg/1 tablet, listed with the FDA by Solco Healthcare US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quinapril.
- What is the active ingredient?
- Quinapril hydrochloride.
- Who is the labeler?
- Solco Healthcare US, 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 Quinapril?
- 30 other product NDCs are listed under this name. See all Quinapril NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Quinapril products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Quinapril | Quinapril hydrochloride 40 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-737 | 51655-0737-52 |
| Quinapril | Quinapril hydrochloride 5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-410 | 43547-0410-09 |
| Quinapril | Quinapril hydrochloride 20 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-412 | 43547-0412-09 |
| Quinapril | Quinapril hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8710 | 63629-8710-01 |
| Quinapril | Quinapril hydrochloride 10 mg/1 | TabletOral | Proficient Rx LP | 71205-484 | 71205-0484-3071205-0484-6071205-0484-90 |
| Quinapril | Quinapril hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1134 | 71335-1134-01 |
| Quinapril | Quinapril hydrochloride 5 mg/1 | TabletOral | Cipla USA Inc. | 69097-839 | 69097-0839-0569097-0839-15 |
| Quinapril | Quinapril hydrochloride 10 mg/1 | TabletOral | Cipla USA Inc. | 69097-841 | 69097-0841-0569097-0841-15 |
| Quinapril | Quinapril hydrochloride 20 mg/1 | TabletOral | Cipla USA Inc. | 69097-842 | 69097-0842-0569097-0842-15 |
| Quinapril | Quinapril hydrochloride 40 mg/1 | TabletOral | Cipla USA Inc. | 69097-843 | 69097-0843-0569097-0843-15 |
Other NDCs under ANDA 205823
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 | Solco Healthcare US, LLC | 43547-410 |
| Quinapril | Quinapril hydrochloride 20 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-412 |
| Quinapril | Quinapril hydrochloride 40 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-413 |
| Quinapril | Quinapril hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8710 |
| Quinapril | Quinapril hydrochloride 10 mg/1 | TabletOral | Proficient Rx LP | 71205-484 |
| Quinapril | Quinapril hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1134 |