Lisinopril and Hydrochlorothiazide NDC 71610-382

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-382Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0382Add 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	Copy
71610-382-30	71610038230	30 TABLET in 1 BOTTLE (71610-382-30)Marketed from Jan 10, 2020
71610-382-60	71610038260	90 TABLET in 1 BOTTLE (71610-382-60)Marketed from Jan 10, 2020

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 and Hydrochlorothiazide
Generic name (nonproprietary): lisinopril and hydrochlorothiazide tablets
Active ingredients: Lisinopril — 10 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204058
Marketing start: May 1, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin-converting Enzyme Inhibitors (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 71610-382_29eb83f5-d92a-4b6f-acf6-3deecf7c4f9fSPL ID 29eb83f5-d92a-4b6f-acf6-3deecf7c4f9fSPL set ID e2903227-4a79-4a9c-b96b-073b8e41fb01RxCUI 197885, 197886, 197887UNII E7199S1YWR, 0J48LPH2TH
Pharmacologic class: Angiotensin Converting Enzyme Inhibitor; Thiazide Diuretic

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

N471610038230 followed by a unit qualifier and the quantity

Package 71610-0382-30. 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 Jan 13, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Lisinopril and hydrochlorothiazide 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 and hydrochlorothiazide. 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204058

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

FDA NDC Directory listings under ANDA 204058
Product	Strength	Form · route	Labeler	Product NDC
Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets	Lisinopril 20 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Bryant Ranch Prepack	71335-1783
Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets	Lisinopril 20 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2263
Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets	Lisinopril 20 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Exelan Pharmaceuticals, Inc.	76282-448
Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets	Lisinopril 10 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Exelan Pharmaceuticals, Inc.	76282-446
Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets	Lisinopril 20 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Exelan Pharmaceuticals, Inc.	76282-447
Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets	Lisinopril 10 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2291
Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets	Lisinopril 20 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2303
Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets	Lisinopril 10 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	A-S Medication Solutions	50090-6094
Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets	Lisinopril 20 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Cipla USA Inc.	69097-969
Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets	Lisinopril 10 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Cipla USA Inc.	69097-968
Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets	Lisinopril 20 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-374
Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets	Lisinopril 20 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Cipla USA Inc.	69097-971
Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets	Lisinopril 20 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-383
Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets	Lisinopril 10 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Bryant Ranch Prepack	71335-1992