Prescription drug · ANDA
lisinopril NDC 43353-270
Lisinopril 2.5 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43353-270-60 | 43353027060 | 90 TABLET in 1 BOTTLE (43353-270-60)Marketed from Jan 23, 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)
- lisinopril
- Generic name (nonproprietary)
- lisinopril
- Active ingredients
- Lisinopril — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203508
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 43353-270_c7e48d97-db9a-465d-938b-215db53d3f58SPL ID c7e48d97-db9a-465d-938b-215db53d3f58SPL set ID 32eb18bc-a80d-4de1-8f38-e591d8f66870RxCUI 197884, 311353, 311354, 314076, 314077UNII E7199S1YWR
- 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
N443353027060followed by a unit qualifier and the quantityPackage 43353-0270-60. 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 Lisinopril Tablets, USP are indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 lisinopril. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve…
Excerpt only. Read the full label for complete information.
About NDC 43353-270
- What is NDC 43353-270?
- 43353-270 is the product NDC for lisinopril, Lisinopril 2.5 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- lisinopril.
- What is the active ingredient?
- Lisinopril.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for lisinopril?
- 258 other product NDCs are listed under this name. See all lisinopril NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other lisinopril products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lisinopril | Lisinopril 5 mg/1 | TabletOral | Coupler LLC | 67046-2097 | 67046-2097-03 |
| Lisinopril | Lisinopril 10 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-047 | 87441-0047-01 |
| Lisinopril | Lisinopril 20 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-048 | 87441-0048-01 |
| Lisinopril | Lisinopril 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-049 | 87441-0049-01 |
| Lisinopril | Lisinopril 10 mg/1 | TabletOral | Coupler LLC | 67046-0422 | 67046-0422-03 |
| Lisinopril | Lisinopril 20 mg/1 | TabletOral | Coupler LLC | 67046-0423 | 67046-0423-03 |
| Lisinopril | Lisinopril 5 mg/1 | TabletOral | Coupler LLC | 67046-0858 | 67046-0858-03 |
| lisinopril | Lisinopril 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4509 | 70518-4509-00 |
| Lisinopril | Lisinopril 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4397 | 70518-4397-00 |
| Lisinopril | Lisinopril 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8562 | 68788-8562-0168788-8562-0368788-8562-06+1 more |
Other NDCs under ANDA 203508
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 |
|---|---|---|---|---|
| lisinopril | Lisinopril 40 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-009 |
| lisinopril | Lisinopril 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-271 |
| lisinopril | Lisinopril 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-298 |
| lisinopril | Lisinopril 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-301 |
| lisinopril | Lisinopril 2.5 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-417 |
| lisinopril | Lisinopril 5 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-418 |
| lisinopril | Lisinopril 10 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-419 |
| lisinopril | Lisinopril 20 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-420 |
| lisinopril | Lisinopril 30 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-421 |
| lisinopril | Lisinopril 40 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-422 |