Prescription drug · ANDA
Quinapril and Hydrochlorothiazide NDC 62135-667
Quinapril hydrochloride 10 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-667-90 | 62135066790 | 90 TABLET in 1 BOTTLE (62135-667-90)Marketed from Dec 5, 2023 |
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 and Hydrochlorothiazide
- Generic name (nonproprietary)
- quinapril and hydrochlorothiazide
- Active ingredients
- Quinapril hydrochloride — 10 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- 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 62135-667_0c3f4504-d57e-aa79-e063-6294a90ad5b8SPL ID 0c3f4504-d57e-aa79-e063-6294a90ad5b8SPL set ID 2eae533f-d0af-47e8-a1f2-94bc8cc89b5aRxCUI 310796, 310797, 310809UNII 33067B3N2M, 0J48LPH2THUPC 0362135669904, 0362135667900, 0362135668907
- 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
N462135066790followed by a unit qualifier and the quantityPackage 62135-0667-90. 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, lipid …
Excerpt only. Read the full label for complete information.
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 HCL and Hydrochlorothiazide | Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Lupin Pharmaceuticals,Inc. | 43386-712 |
| Quinapril HCL and Hydrochlorothiazide | Quinapril hydrochloride 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Lupin Pharmaceuticals,Inc. | 43386-710 |
| Quinapril HCL and Hydrochlorothiazide | Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Lupin Pharmaceuticals,Inc. | 43386-711 |
| Quinapril and Hydrochlorothiazide | Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Chartwell RX, LLC | 62135-669 |
| Quinapril and Hydrochlorothiazide | Quinapril hydrochloride 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Chartwell RX, LLC | 62135-668 |