Prescription drug · ANDA
Lisinopril NDC 43063-786
Lisinopril 20 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-786-14 | 43063078614 | 14 TABLET in 1 BOTTLE, PLASTIC (43063-786-14)Marketed from Aug 31, 2017 | |
| 43063-786-30 | 43063078630 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-786-30)Marketed from Aug 31, 2017 | |
| 43063-786-60 | 43063078660 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-786-60)Marketed from Sep 20, 2017 | |
| 43063-786-90 | 43063078690 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-786-90)Marketed from Aug 31, 2017 | |
| 43063-786-93 | 43063078693 | 180 TABLET in 1 BOTTLE, PLASTIC (43063-786-93)Marketed from Sep 28, 2017 | |
| 43063-786-98 | 43063078698 | 120 TABLET in 1 BOTTLE, PLASTIC (43063-786-98)Marketed from Oct 3, 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 — 20 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 076164
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 43063-786_32850517-fae5-3e53-e063-6294a90adf73SPL ID 32850517-fae5-3e53-e063-6294a90adf73SPL set ID e4c11545-00da-4675-856a-7e600a2f4bd9RxCUI 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
N443063078614followed by a unit qualifier and the quantityPackage 43063-0786-14. 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, USP, 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 43063-786
- What is NDC 43063-786?
- 43063-786 is the product NDC for Lisinopril, Lisinopril 20 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 6 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 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 076164
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 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-769 |
| Lisinopril | Lisinopril 40 mg/1 | TabletOral | Quality Care Products LLC | 55700-547 |
| Lisinopril | Lisinopril 20 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-359 |
| Lisinopril | Lisinopril 40 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-360 |
| Lisinopril | Lisinopril 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0176 |
| Lisinopril | Lisinopril 10 mg/1 | TabletOral | QPharma, Inc. | 42708-094 |
| Lisinopril | Lisinopril 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-399 |
| Lisinopril | Lisinopril 40 mg/1 | TabletOral | QPharma, Inc. | 42708-096 |
| Lisinopril | Lisinopril 20 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-411 |
| Lisinopril | Lisinopril 30 mg/1 | TabletOral | A-S Medication Solutions | 50090-2934 |
| Lisinopril | Lisinopril 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-1775 |
| Lisinopril | Lisinopril 2.5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-340 |
| Lisinopril | Lisinopril 40 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-800 |
| Lisinopril | Lisinopril 30 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-344 |
| Lisinopril | Lisinopril 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-341 |
| Lisinopril | Lisinopril 10 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-342 |
| Lisinopril | Lisinopril 20 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-343 |
| Lisinopril | Lisinopril 40 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-345 |
| Lisinopril | Lisinopril 5 mg/1 | TabletOral | Coupler LLC | 67046-2097 |
| Lisinopril | Lisinopril 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-6920 |
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