Prescription drug · NDA AUTHORIZED GENERIC
Diltiazem Hydrochloride NDC 68682-705
diltiazem hydrochloride extended-release tablets · Diltiazem hydrochloride 180 mg/1 · Tablet, Extended release · Oral · Oceanside Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68682-705-30 | 68682070530 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-705-30)Marketed from Feb 6, 2014 | |
| 68682-705-90 | 68682070590 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-705-90)Marketed from Feb 6, 2014 |
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)
- Diltiazem Hydrochloride
- Generic name (nonproprietary)
- diltiazem hydrochloride extended-release tablets
- Active ingredients
- Diltiazem hydrochloride — 180 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Oceanside Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021392
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 68682-705_9c3468f2-1199-4180-9e57-089b5353251aSPL ID 9c3468f2-1199-4180-9e57-089b5353251aSPL set ID 73b3607a-99d0-44d8-92ef-0074684c9d7dRxCUI 830874, 830877, 830879, 830882, 830897, 830900UNII OLH94387TE
- Pharmacologic class
- Calcium Channel Blocker
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
N468682070530followed by a unit qualifier and the quantityPackage 68682-0705-30. 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 .
Indications (excerpt from the label)
Diltiazem Hydrochloride Extended-Release Tablets is a nondihydropyridine calcium channel blocker indicated for: • treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It can be used alone or in combination with other antihypertensives. ( 1.1 ) • improving exercise tolerance in patients with chronic stable angina. ( 1.2 ) 1.1 Hypertension Diltiazem Hydrochloride Extended-Release Tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes an…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021392
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 |
|---|---|---|---|---|
| Cardizem LAdiltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Bausch Health US LLC | 0187-2045 |
| Cardizem LAdiltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Tablet, Extended releaseOral | Bausch Health US LLC | 0187-2046 |
| Cardizem LAdiltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Tablet, Extended releaseOral | Bausch Health US LLC | 0187-2047 |
| Cardizem LAdiltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Bausch Health US LLC | 0187-2048 |
| Diltiazem Hydrochloridediltiazem hydrochloride extended-release tablets | Diltiazem hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Oceanside Pharmaceuticals | 68682-704 |
| Diltiazem Hydrochloridediltiazem hydrochloride extended-release tablets | Diltiazem hydrochloride 360 mg/1 | Tablet, Extended releaseOral | Oceanside Pharmaceuticals | 68682-708 |
| Diltiazem Hydrochloridediltiazem hydrochloride extended-release tablets | Diltiazem hydrochloride 240 mg/1 | Tablet, Extended releaseOral | Oceanside Pharmaceuticals | 68682-706 |
| Diltiazem Hydrochloridediltiazem hydrochloride extended-release tablets | Diltiazem hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Oceanside Pharmaceuticals | 68682-707 |
| Diltiazem Hydrochloridediltiazem hydrochloride extended-release tablets | Diltiazem hydrochloride 420 mg/1 | Tablet, Extended releaseOral | Oceanside Pharmaceuticals | 68682-709 |
| Cardizem LAdiltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Tablet, Extended releaseOral | Bausch Health US LLC | 0187-2049 |
| Cardizem LAdiltiazem hydrochloride | Diltiazem hydrochloride 420 mg/1 | Tablet, Extended releaseOral | Bausch Health US LLC | 0187-2050 |