Prescription drug · ANDA
Lisinopril and Hydrochlorothiazide NDC 43063-468
Hydrochlorothiazide 25 mg/1; Lisinopril 20 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-468-30 | 43063046830 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-468-30)Marketed from Sep 13, 2013 | |
| 43063-468-90 | 43063046890 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-468-90)Marketed from Sep 13, 2013 |
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
- Hydrochlorothiazide — 25 mg/1Lisinopril — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077912
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 43063-468_47d238b7-b5d5-0e63-e063-6294a90a8027SPL ID 47d238b7-b5d5-0e63-e063-6294a90a8027SPL set ID 00f67e1a-6999-4295-9c9f-fcb1ce9711b8RxCUI 197887UNII 0J48LPH2TH, E7199S1YWRUPC 0343063468302
- 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
N443063046830followed by a unit qualifier and the quantityPackage 43063-0468-30. 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 . 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 077912
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 | Hydrochlorothiazide 12.5 mg/1; Lisinopril 10 mg/1 | TabletOral | QPharma, Inc. | 42708-150 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-412 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Lisinopril 20 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-413 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Lisinopril 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0174 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0196 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Lisinopril 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-6976 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0382 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 20 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-519 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 10 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-518 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Lisinopril 20 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-520 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Lisinopril 20 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-1945 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 20 mg/1 | TabletOral | Proficient Rx LP | 71205-022 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2183 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Lisinopril 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-3739 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-4470 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 20 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3177 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 20 mg/1 | TabletOral | Coupler LLC | 67046-0433 |
| Lisinopril And Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 10 mg/1 | TabletOral | Proficient Rx LP | 63187-319 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 20 mg/1 | TabletOral | Legacy Pharmaceutical Packaging, LLC | 68645-557 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 10 mg/1 | TabletOral | Legacy Pharmaceutical Packaging, LLC | 68645-556 |
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