Prescription drug · ANDA
Lisinopril and hydrochlorothiazide NDC 63187-050
Lisinopril 20 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-050-00 | 63187005000 | 100 TABLET in 1 BOTTLE, PLASTIC (63187-050-00)Marketed from Jul 14, 2020 | |
| 63187-050-30 | 63187005030 | 30 TABLET in 1 BOTTLE, PLASTIC (63187-050-30)Marketed from Nov 1, 2018 | |
| 63187-050-60 | 63187005060 | 60 TABLET in 1 BOTTLE, PLASTIC (63187-050-60)Marketed from Jul 14, 2020 | |
| 63187-050-90 | 63187005090 | 90 TABLET in 1 BOTTLE, PLASTIC (63187-050-90)Marketed from Jul 14, 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
- Active ingredients
- Lisinopril — 20 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076194
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 63187-050_f91a5b3e-4e83-45ec-a1a0-b815de7e1876SPL ID f91a5b3e-4e83-45ec-a1a0-b815de7e1876SPL set ID af0b3bef-be36-432a-884e-ea81e2d5c08eRxCUI 197886, 197887UNII E7199S1YWR, 0J48LPH2THUPC 0363187051303, 0363187050900
- 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
N463187005000followed by a unit qualifier and the quantityPackage 63187-0050-00. 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 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 requi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076194
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 Hydrochlorothiazide | Lisinopril 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-414 |
| Lisinopril and Hydrochlorothiazide | Lisinopril 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0862 |
| Lisinopril and Hydrochlorothiazide | Lisinopril 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4435 |
| Lisinopril and hydrochlorothiazide | Lisinopril 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | NuCarePharmaceuticals, Inc. | 68071-3008 |
| Lisinopril and Hydrochlorothiazide | Lisinopril 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-0860 |
| Lisinopril and Hydrochlorothiazide | Lisinopril 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-0861 |
| Lisinopril and Hydrochlorothiazide | Lisinopril 20 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-0862 |
| Lisinopril and hydrochlorothiazide | Lisinopril 20 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Proficient Rx LP | 63187-051 |
| Lisinopril and Hydrochlorothiazide | Lisinopril 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-274 |
| Lisinopril and Hydrochlorothiazide | Lisinopril 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | QPharma Inc | 42708-034 |