Prescription drug · ANDA
Benazepril Hydrochloride and Hydrochlorothiazide NDC 68462-579
Benazepril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet, Film coated · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-579-01 | 6846205790168462057901 | 100 TABLET, FILM COATED in 1 BOTTLE (68462-579-01)Marketed from Dec 1, 2023 |
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)
- Benazepril Hydrochloride and Hydrochlorothiazide
- Generic name (nonproprietary)
- benazepril hydrochloride and hydrochlorothiazide
- Active ingredients
- Benazepril hydrochloride — 20 mg/1Hydrochlorothiazide — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076631
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 68462-579_51b0aed8-a229-4d2c-8fdf-aa957fddc41bSPL ID 51b0aed8-a229-4d2c-8fdf-aa957fddc41bSPL set ID 51b0aed8-a229-4d2c-8fdf-aa957fddc41bRxCUI 898362, 898367, 898372, 898378UNII 0J48LPH2TH, N1SN99T69TUPC 0368462579015, 0368462576014, 0368462578018
- 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
N468462057901followed by a unit qualifier and the quantityPackage 68462-0579-01. 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 Benazepril hydrochloride and hydrochlorothiazide tablets are indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION ).
Excerpt only. Read the full label for complete information.
About NDC 68462-579
- What is NDC 68462-579?
- 68462-579 is the product NDC for Benazepril Hydrochloride and Hydrochlorothiazide, Benazepril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Benazepril Hydrochloride and Hydrochlorothiazide.
- What is the active ingredient?
- Benazepril hydrochloride, Hydrochlorothiazide.
- Who is the labeler?
- Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Benazepril Hydrochloride and Hydrochlorothiazide?
- 17 other product NDCs are listed under this name. See all Benazepril Hydrochloride 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 Benazepril Hydrochloride 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) |
|---|---|---|---|---|---|
| benazepril hydrochloride and hydrochlorothiazide | Benazepril hydrochloride 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-220 | 72888-0220-01 |
| benazepril hydrochloride and hydrochlorothiazide | Benazepril hydrochloride 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-221 | 72888-0221-01 |
| benazepril hydrochloride and hydrochlorothiazide | Benazepril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-222 | 72888-0222-01 |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril hydrochloride 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-414 | 62559-0414-01 |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril hydrochloride 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-415 | 62559-0415-01 |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril hydrochloride 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-416 | 62559-0416-01 |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-417 | 62559-0417-01 |
| benazepril hydrochloride and hydrochlorothiazide | Benazepril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Padagis US LLC | 0574-0228 | 00574-0228-01 |
| benazepril hydrochloride and hydrochlorothiazide | Benazepril hydrochloride 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Padagis US LLC | 0574-0229 | 00574-0229-01 |
| benazepril hydrochloride and hydrochlorothiazide | Benazepril hydrochloride 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2328 | 72162-2328-01 |
All 18 Benazepril Hydrochloride and Hydrochlorothiazide NDCs
Other NDCs under ANDA 076631
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 |
|---|---|---|---|---|
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril hydrochloride 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0185-0211 |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril hydrochloride 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0185-0236 |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0185-0277 |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril hydrochloride 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0185-0325 |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril hydrochloride 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-576 |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril hydrochloride 10 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-577 |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril hydrochloride 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-578 |