Prescription drug · ANDA
Lisinopril and Hydrochlorothiazide NDC 71335-0479
Hydrochlorothiazide 12.5 mg/1; Lisinopril 10 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0479-1 | 71335047901 | 90 TABLET in 1 BOTTLE (71335-0479-1)Marketed from Nov 23, 2021 | |
| 71335-0479-2 | 71335047902 | 60 TABLET in 1 BOTTLE (71335-0479-2)Marketed from Apr 3, 2024 | |
| 71335-0479-3 | 71335047903 | 30 TABLET in 1 BOTTLE (71335-0479-3)Marketed from Feb 25, 2022 | |
| 71335-0479-4 | 71335047904 | 100 TABLET in 1 BOTTLE (71335-0479-4)Marketed from Apr 3, 2024 | |
| 71335-0479-5 | 71335047905 | 120 TABLET in 1 BOTTLE (71335-0479-5)Marketed from Apr 3, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 12.5 mg/1Lisinopril — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 71335-0479_b6aa4a0a-8410-45e6-8010-674484fb69a1SPL ID b6aa4a0a-8410-45e6-8010-674484fb69a1SPL set ID 544b75eb-55f1-4164-9b83-39f6bc5fb479RxCUI 197885UNII 0J48LPH2TH, E7199S1YWR
- 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
N471335047901followed by a unit qualifier and the quantityPackage 71335-0479-01. 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 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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