Prescription drug · ANDA
Lisinopril and Hydrochlorothiazide NDC 63629-4470
Hydrochlorothiazide 12.5 mg/1; Lisinopril 20 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-4470-1 | 6362944700163629447001 | 30 TABLET in 1 BOTTLE (63629-4470-1)Marketed from Mar 24, 2011 | |
| 63629-4470-2 | 6362944700263629447002 | 90 TABLET in 1 BOTTLE (63629-4470-2)Marketed from May 16, 2011 | |
| 63629-4470-3 | 6362944700363629447003 | 100 TABLET in 1 BOTTLE (63629-4470-3)Marketed from Dec 22, 2021 | |
| 63629-4470-4 | 6362944700463629447004 | 60 TABLET in 1 BOTTLE (63629-4470-4)Marketed from Feb 10, 2015 | |
| 63629-4470-5 | 6362944700563629447005 | 360 TABLET in 1 BOTTLE (63629-4470-5)Marketed from Dec 22, 2021 | |
| 63629-4470-6 | 6362944700663629447006 | 4 TABLET in 1 BOTTLE (63629-4470-6)Marketed from Dec 22, 2021 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- 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 63629-4470_6ae03122-17fd-405e-9951-bac76256e28aSPL ID 6ae03122-17fd-405e-9951-bac76256e28aSPL set ID 019ac336-0dc3-ec89-3e0a-09110e0fc30bRxCUI 197886UNII 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
N463629447001followed by a unit qualifier and the quantityPackage 63629-4470-01. 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.
About NDC 63629-4470
- What is NDC 63629-4470?
- 63629-4470 is the product NDC for Lisinopril and Hydrochlorothiazide, Hydrochlorothiazide 12.5 mg/1; Lisinopril 20 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lisinopril and Hydrochlorothiazide.
- What is the active ingredient?
- Hydrochlorothiazide, Lisinopril.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lisinopril and Hydrochlorothiazide?
- 85 other product NDCs are listed under this name. See all Lisinopril and Hydrochlorothiazide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lisinopril and Hydrochlorothiazide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 20 mg/1 | TabletOral | Coupler LLC | 67046-0433 | 67046-0433-03 |
| Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets | Lisinopril 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4516 | 70518-4516-0070518-4516-01 |
| LISINOPRIL and HYDROCHLOROTHIAZIDE | Lisinopril 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | GSMS, Incorporated | 51407-564 | 51407-0564-0551407-0564-90 |
| LISINOPRIL and HYDROCHLOROTHIAZIDE | Lisinopril 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | GSMS, Incorporated | 51407-565 | 51407-0565-0551407-0565-90 |
| LISINOPRIL and HYDROCHLOROTHIAZIDE | Lisinopril 20 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | GSMS, Incorporated | 51407-566 | 51407-0566-0551407-0566-90 |
| Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets | Lisinopril 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-586 | 60760-0586-90 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 10 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0207 | 80425-0207-03 |
| Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets | Lisinopril 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8253 | 68788-8253-0168788-8253-0368788-8253-06+1 more |
| Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets | Lisinopril 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8224 | 68788-8224-0168788-8224-0368788-8224-06+1 more |
| Lisinopril and Hydrochlorothiazidelisinopril and hydrochlorothiazide tablets | Lisinopril 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3505 | 70518-3505-0070518-3505-0170518-3505-02+1 more |
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 25 mg/1; Lisinopril 20 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9808 |
| Lisinopril And Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 10 mg/1 | TabletOral | St Marys Medical Park Pharmacy | 60760-063 |
| Lisinopril And Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 20 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9809 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-838 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-2565 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0479 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 10 mg/1 | TabletOral | QPharma, Inc. | 42708-150 |
| Lisinopril And Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Lisinopril 20 mg/1 | TabletOral | Proficient Rx LP | 63187-467 |
| Lisinopril And Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Lisinopril 10 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9807 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Lisinopril 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-6976 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Lisinopril 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-2974 |
| 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 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 12.5 mg/1; Lisinopril 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0382 |
| 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 | PD-Rx Pharmaceuticals, Inc. | 43063-458 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Lisinopril 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-3739 |
| Lisinopril and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Lisinopril 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-468 |
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