What is NDC 43353-301?

43353-301 is the product NDC for lisinopril, Lisinopril 10 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.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

lisinopril NDC 43353-301 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-301Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0301Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
43353-301-30	43353030130	30 TABLET in 1 BOTTLE (43353-301-30)Marketed from Apr 4, 2017
43353-301-45	43353030145	45 TABLET in 1 BOTTLE (43353-301-45)Marketed from Mar 9, 2021
43353-301-60	43353030160	90 TABLET in 1 BOTTLE (43353-301-60)Marketed from Feb 12, 2021

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 — 10 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: Mar 15, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin-converting Enzyme Inhibitors (Mechanism)
Identifiers: Product ID 43353-301_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

N443353030130 followed by a unit qualifier and the quantity

Package 43353-0301-30. 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 Aug 10, 2021. 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.

Full label on DailyMed (opens in a new tab)

About NDC 43353-301

What is NDC 43353-301?: 43353-301 is the product NDC for lisinopril, Lisinopril 10 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 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other lisinopril NDCs
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

All 259 lisinopril NDCs

Other NDCs under ANDA 203508

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203508
Product	Strength	Form · route	Labeler	Product NDC
lisinopril	Lisinopril 40 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	43353-009
lisinopril	Lisinopril 2.5 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	43353-270
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 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