Prescription drug · ANDA
Quinapril (Quinapril hydrochloride) NDC 65862-619
Quinapril hydrochloride 20 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-619-19 | 65862061919 | 10000 TABLET, FILM COATED in 1 BOTTLE (65862-619-19)Marketed from Apr 29, 2013 | |
| 65862-619-30 | 65862061930 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-619-30)Marketed from Apr 29, 2013 | |
| 65862-619-78 | 65862061978 | 10 BLISTER PACK in 1 CARTON (65862-619-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-619-10)Marketed from Apr 29, 2013 | |
| 65862-619-90 | 65862061990 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-619-90)Marketed from Apr 29, 2013 | |
| 65862-619-99 | 65862061999 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-619-99)Marketed from Apr 29, 2013 |
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 hydrochloride
- Active ingredients
- Quinapril hydrochloride — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202725
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-619_5263abd5-ce46-4918-9bb0-9632861bcbc9SPL ID 5263abd5-ce46-4918-9bb0-9632861bcbc9SPL set ID 93e6e668-5306-4f26-81d8-cbc3a7a5e787RxCUI 312748, 312749, 312750, 314203UNII 33067B3N2MUPC 0365862618900, 0365862617903, 0365862619907
- 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
N465862061919followed by a unit qualifier and the quantityPackage 65862-0619-19. 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 tablets, USP 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, USP. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithr…
Excerpt only. Read the full label for complete information.
About NDC 65862-619
- What is NDC 65862-619?
- 65862-619 is the product NDC for Quinapril (quinapril hydrochloride), Quinapril hydrochloride 20 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quinapril (Quinapril Hydrochloride).
- What is the active ingredient?
- Quinapril hydrochloride.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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 10 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-411 | 43547-0411-09 |
| 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 |
Other NDCs under ANDA 202725
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 |
|---|---|---|---|---|
| Quinaprilquinapril hydrochloride | Quinapril hydrochloride 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-874 |
| Quinaprilquinapril hydrochloride | Quinapril hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-7934 |
| Quinaprilquinapril hydrochloride | Quinapril hydrochloride 40 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-620 |