Prescription drug · ANDA
LISINOPRIL and HYDROCHLOROTHIAZIDE NDC 51407-564
Lisinopril 10 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · GSMS, Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-564-05 | 51407056405 | 500 TABLET in 1 BOTTLE (51407-564-05)Marketed from Feb 15, 2025 | |
| 51407-564-90 | 51407056490 | 90 TABLET in 1 BOTTLE (51407-564-90)Marketed from Feb 15, 2025 |
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 — 10 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- GSMS, Incorporated
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076674
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 51407-564_fd91c3d4-99e0-4b5d-8f6c-d08f19b64703SPL ID fd91c3d4-99e0-4b5d-8f6c-d08f19b64703SPL set ID d02a0d38-676a-4e0f-9aa2-0a6c56cd7361RxCUI 197885, 197886, 197887UNII E7199S1YWR, 0J48LPH2THUPC 0351407565907, 0351407566904, 0351407565051, 0351407566058, 0351407564054, 0351407564900
- 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
N451407056405followed by a unit qualifier and the quantityPackage 51407-0564-05. 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 requ…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076674
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 | GSMS, Incorporated | 51407-565 |
| LISINOPRIL and HYDROCHLOROTHIAZIDE | Lisinopril 20 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | GSMS, Incorporated | 51407-566 |