Prescription drug · NDA
Zestoretic (Lisinopril and hydrochlorothiazide) NDC 52427-435
Lisinopril 10 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Almatica Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52427-435-90 | 52427043590 | 90 TABLET in 1 BOTTLE (52427-435-90)Marketed from Apr 15, 2015 |
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)
- Zestoretic
- Generic name (nonproprietary)
- lisinopril and hydrochlorothiazide
- Active ingredients
- Lisinopril — 10 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Almatica Pharma Inc.NDC labeler code 52427
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019888
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 52427-435_b8a81227-c1af-6093-4d92-647ad3fee155SPL ID b8a81227-c1af-6093-4d92-647ad3fee155SPL set ID 0d3a966f-f937-05a8-a90f-5aa52ebbd613RxCUI 197885, 197886, 197887, 823971, 823982, 823986UNII 0J48LPH2TH, E7199S1YWRUPC 0352427435904, 0352427436901, 0352427437908
- 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
N452427043590followed by a unit qualifier and the quantityPackage 52427-0435-90. 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 ZESTORETIC is 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 require more than 1 drug to achieve b…
Excerpt only. Read the full label for complete information.
About NDC 52427-435
- What is NDC 52427-435?
- 52427-435 is the product NDC for Zestoretic, Lisinopril 10 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, listed with the FDA by Almatica Pharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zestoretic (Lisinopril and hydrochlorothiazide).
- What is the active ingredient?
- Lisinopril, Hydrochlorothiazide.
- Who is the labeler?
- Almatica Pharma Inc., NDC labeler code 52427. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zestoretic?
- 2 other product NDCs are listed under this name. See all Zestoretic NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zestoretic products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zestoreticlisinopril and hydrochlorothiazide | Lisinopril 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Almatica Pharma Inc. | 52427-436 | 52427-0436-90 |
| Zestoreticlisinopril and hydrochlorothiazide | Lisinopril 20 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Almatica Pharma Inc. | 52427-437 | 52427-0437-90 |
Other NDCs under NDA 019888
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 |
|---|---|---|---|---|
| Zestoreticlisinopril and hydrochlorothiazide | Lisinopril 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Almatica Pharma Inc. | 52427-436 |
| Zestoreticlisinopril and hydrochlorothiazide | Lisinopril 20 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Almatica Pharma Inc. | 52427-437 |