Prescription drug · ANDA
Quinapril HCL and Hydrochlorothiazide NDC 43386-710
Quinapril hydrochloride 10 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43386-710-05 | 4338607100543386071005 | 500 TABLET in 1 BOTTLE (43386-710-05)Marketed from Jul 15, 2011 | |
| 43386-710-09 | 4338607100943386071009 | 90 TABLET in 1 BOTTLE (43386-710-09)Marketed from Jul 15, 2011 |
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 HCL and Hydrochlorothiazide
- Generic name (nonproprietary)
- quinapril hcl and hydrochlorothiazide
- Active ingredients
- Quinapril hydrochloride — 10 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals,Inc.NDC labeler code 43386
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076374
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 43386-710_916f3e69-0d6e-4524-8abe-afb2e134eec2SPL ID 916f3e69-0d6e-4524-8abe-afb2e134eec2SPL set ID 383ecaa6-29c8-4280-a442-c47f101d7c88RxCUI 310796, 310797, 310809UNII 0J48LPH2TH, 33067B3N2M
- Pharmacologic class
- Angiotensin Converting Enzyme Inhibitor; Thiazide Diuretic
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
N443386071005followed by a unit qualifier and the quantityPackage 43386-0710-05. 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 and Hydrochlorothiazide Tablets 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 and Hydrochlorothiazide Tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipi…
Excerpt only. Read the full label for complete information.
About NDC 43386-710
- What is NDC 43386-710?
- 43386-710 is the product NDC for Quinapril HCL and Hydrochlorothiazide, Quinapril hydrochloride 10 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quinapril HCL and Hydrochlorothiazide.
- What is the active ingredient?
- Quinapril hydrochloride, Hydrochlorothiazide.
- Who is the labeler?
- Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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 HCL and Hydrochlorothiazide?
- 2 other product NDCs are listed under this name. See all Quinapril HCL and Hydrochlorothiazide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Quinapril HCL and Hydrochlorothiazide 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 HCL and Hydrochlorothiazide | Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Lupin Pharmaceuticals,Inc. | 43386-711 | 43386-0711-0543386-0711-09 |
| Quinapril HCL and Hydrochlorothiazide | Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Lupin Pharmaceuticals,Inc. | 43386-712 | 43386-0712-0543386-0712-09 |
Other NDCs under ANDA 076374
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 and Hydrochlorothiazide | Quinapril hydrochloride 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Chartwell RX, LLC | 62135-667 |
| Quinapril and Hydrochlorothiazide | Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Chartwell RX, LLC | 62135-668 |
| Quinapril and Hydrochlorothiazide | Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Chartwell RX, LLC | 62135-669 |
| Quinapril HCL and Hydrochlorothiazide | Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Lupin Pharmaceuticals,Inc. | 43386-711 |
| Quinapril HCL and Hydrochlorothiazide | Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Lupin Pharmaceuticals,Inc. | 43386-712 |