Prescription drug · ANDA
Lisinopril NDC 71610-624
Lisinopril 40 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-624-45 | 71610062445 | 45 TABLET in 1 BOTTLE (71610-624-45)Marketed from Dec 6, 2021 | |
| 71610-624-60 | 71610062460 | 90 TABLET in 1 BOTTLE (71610-624-60)Marketed from Dec 6, 2021 | |
| 71610-624-80 | 71610062480 | 180 TABLET in 1 BOTTLE (71610-624-80)Marketed from Feb 7, 2022 |
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
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077321
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 71610-624_6224d557-1df2-46fb-bebd-eb8bdf81c897SPL ID 6224d557-1df2-46fb-bebd-eb8bdf81c897SPL set ID 1b9ddfd8-0acc-4fb5-a948-bb2c0cc23a91RxCUI 197884UNII 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
N471610062445followed by a unit qualifier and the quantityPackage 71610-0624-45. 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 tablet USP 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 tablet USP is 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 class…
Excerpt only. Read the full label for complete information.
About NDC 71610-624
- What is NDC 71610-624?
- 71610-624 is the product NDC for Lisinopril, Lisinopril 40 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 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?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 077321
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 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-093 |
| Lisinopril | Lisinopril 40 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-146 |
| Lisinopril | Lisinopril 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8254 |
| Lisinopril | Lisinopril 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1152 |
| Lisinopril | Lisinopril 20 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8255 |
| Lisinopril | Lisinopril 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1156 |
| Lisinopril | Lisinopril 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5247 |
| Lisinopril | Lisinopril 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3411 |
| Lisinopril | Lisinopril 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-8007 |
| Lisinopril | Lisinopril 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5382 |
| Lisinopril | Lisinopril 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3409 |
| Lisinopril | Lisinopril 2.5 mg/1 | TabletOral | American Health Packaging | 60687-656 |
| Lisinopril | Lisinopril 5 mg/1 | TabletOral | American Health Packaging | 60687-667 |
| Lisinopril | Lisinopril 40 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7200 |
| Lisinopril | Lisinopril 5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-232 |
| Lisinopril | Lisinopril 5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-232 |
| Lisinopril | Lisinopril 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-638 |
| Lisinopril | Lisinopril 40 mg/1 | TabletOral | American Health Packaging | 60687-678 |
| Lisinopril | Lisinopril 5 mg/1 | TabletOral | Proficient Rx LP | 71205-471 |
| Lisinopril | Lisinopril 30 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2561 |
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