Prescription drug · ANDA
Lisinopril NDC 43547-415
Lisinopril 5 mg/1 · Tablet · Oral · Solco healthcare U.S., LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-415-03 | 43547041503 | 30 TABLET in 1 BOTTLE (43547-415-03)Marketed from Aug 30, 2017 | |
| 43547-415-04 | 43547041504 | 45 TABLET in 1 BOTTLE (43547-415-04)Marketed from Aug 30, 2017 | |
| 43547-415-09 | 43547041509 | 90 TABLET in 1 BOTTLE (43547-415-09)Marketed from Aug 30, 2017 | |
| 43547-415-10 | 43547041510 | 100 TABLET in 1 BOTTLE (43547-415-10)Marketed from Aug 30, 2017 | |
| 43547-415-11 | 43547041511 | 1000 TABLET in 1 BOTTLE (43547-415-11)Marketed from Aug 30, 2017 | |
| 43547-415-25 | 43547041525 | 2500 TABLET in 1 BOTTLE (43547-415-25)Marketed from Aug 30, 2017 | |
| 43547-415-50 | 43547041550 | 500 TABLET in 1 BOTTLE (43547-415-50)Marketed from Aug 30, 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solco healthcare U.S., LLCNDC labeler code 43547
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075743
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 43547-415_1ed80b02-cb3b-41c5-ab33-ff0106b8792dSPL ID 1ed80b02-cb3b-41c5-ab33-ff0106b8792dSPL set ID f8d16c85-50e2-4d99-afae-6fb902734e42RxCUI 197884, 205326, 311353, 311354, 314076, 314077UNII E7199S1YWRUPC 0343547414108
- 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
N443547041503followed by a unit qualifier and the quantityPackage 43547-0415-03. 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)
Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: • Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1) • Adjunct therapy for heart failure (1.2) • Treatment of Acute Myocardial Infarction (1.3) 1.1 Hypertension Lisinopril tablets are indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older 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. Control o…
Excerpt only. Read the full label for complete information.
About NDC 43547-415
- What is NDC 43547-415?
- 43547-415 is the product NDC for Lisinopril, Lisinopril 5 mg/1 tablet, listed with the FDA by Solco healthcare U.S., LLC. It has 7 package NDCs, 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?
- Solco healthcare U.S., 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 Lisinopril?
- 267 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 20 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-048 | 87441-0048-01 |
| Lisinopril | Lisinopril 10 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-047 | 87441-0047-01 |
| 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 075743
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 2.5 mg/1 | TabletOral | Solco healthcare U.S., LLC | 43547-414 |
| Lisinopril | Lisinopril 10 mg/1 | TabletOral | Solco healthcare U.S., LLC | 43547-416 |
| Lisinopril | Lisinopril 20 mg/1 | TabletOral | Solco healthcare U.S., LLC | 43547-417 |
| Lisinopril | Lisinopril 40 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-406 |
| Lisinopril | Lisinopril 2.5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-741 |
| Lisinopril | Lisinopril 2.5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-810 |
| Lisinopril | Lisinopril 5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-811 |
| Lisinopril | Lisinopril 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-812 |
| Lisinopril | Lisinopril 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-813 |
| Lisinopril | Lisinopril 30 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-814 |
| Lisinopril | Lisinopril 40 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-815 |
| Lisinopril | Lisinopril 30 mg/1 | TabletOral | Solco healthcare U.S., LLC | 43547-418 |
| Lisinopril | Lisinopril 40 mg/1 | TabletOral | Solco healthcare U.S., LLC | 43547-419 |