Prescription drug · ANDA
Benazepril Hydrochloride and Hydrochlorothiazide NDC 0185-0211
Benazepril hydrochloride 20 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet, Film coated · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0185-0211-01 | 00185021101 | 100 TABLET, FILM COATED in 1 BOTTLE (0185-0211-01)Marketed from Feb 11, 2004 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 12.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sandoz Inc
- 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 0185-0211_d9ded9f8-b60e-4325-a813-44b5ee485accSPL ID d9ded9f8-b60e-4325-a813-44b5ee485accSPL set ID c9bdfbb4-87b6-4de4-bc1d-5025d3ef591fRxCUI 898362, 898367, 898372, 898378UNII N1SN99T69T, 0J48LPH2THUPC 0301850325016, 0301850236015, 0301850277018, 0301850211012
- 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
N400185021101followed by a unit qualifier and the quantityPackage 00185-0211-01. 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.
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 | Glenmark Pharmaceuticals Inc., USA | 68462-578 |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-579 |
| 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 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-576 |
| 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 |