Prescription drug · ANDA
Lisinopril and Hydrochlorothiazide NDC 76282-446
lisinopril and hydrochlorothiazide tablets · Lisinopril 10 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Exelan Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-446-01 | 76282044601 | 100 TABLET in 1 BOTTLE (76282-446-01)Marketed from May 1, 2019 | |
| 76282-446-05 | 76282044605 | 500 TABLET in 1 BOTTLE (76282-446-05)Marketed from May 1, 2019 | |
| 76282-446-10 | 76282044610 | 1000 TABLET in 1 BOTTLE (76282-446-10)Marketed from May 1, 2019 | |
| 76282-446-90 | 76282044690 | 90 TABLET in 1 BOTTLE (76282-446-90)Marketed from May 1, 2019 |
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
- Exelan Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204058
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 76282-446_7f4a4f31-58b0-4fe1-bd11-ba5a6ac4f26cSPL ID 7f4a4f31-58b0-4fe1-bd11-ba5a6ac4f26cSPL set ID c40b15ec-6083-4778-bca8-3e895e5694e1RxCUI 197885, 197886, 197887UNII E7199S1YWR, 0J48LPH2THUPC 0376282448909, 0376282447902, 0376282446905
- 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
N476282044601followed by a unit qualifier and the quantityPackage 76282-0446-01. 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)
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.
Other NDCs under ANDA 204058
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 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 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 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-382 |
| 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 |