Prescription drug · ANDA
Lisinopril NDC 43063-815
Lisinopril 40 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-815-01 | 43063081501 | 100 TABLET in 1 BOTTLE, PLASTIC (43063-815-01)Marketed from Jan 5, 2018 | |
| 43063-815-30 | 43063081530 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-815-30)Marketed from Jan 8, 2018 | |
| 43063-815-60 | 43063081560 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-815-60)Marketed from Jan 11, 2018 | |
| 43063-815-90 | 43063081590 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-815-90)Marketed from Jan 9, 2018 |
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 — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
- 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 43063-815_415b9940-77ea-a174-e063-6294a90a4cfeSPL ID 415b9940-77ea-a174-e063-6294a90a4cfeSPL set ID b62815f3-77fc-4074-a28a-918ab5cc32dbRxCUI 197884, 205326, 311353, 311354, 314076, 314077UNII E7199S1YWRUPC 0343063810019, 0343063814017, 0343063813010, 0343063812013
- 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
N443063081501followed by a unit qualifier and the quantityPackage 43063-0815-01. 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 of high…
Excerpt only. Read the full label for complete information.
About NDC 43063-815
- What is NDC 43063-815?
- 43063-815 is the product NDC for Lisinopril, Lisinopril 40 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 4 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?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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 5 mg/1 | TabletOral | Solco healthcare U.S., LLC | 43547-415 |
| 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 30 mg/1 | TabletOral | Solco healthcare U.S., LLC | 43547-418 |
| Lisinopril | Lisinopril 40 mg/1 | TabletOral | Solco healthcare U.S., LLC | 43547-419 |