Prescription drug · NDA
Cardizem LA (Diltiazem hydrochloride) NDC 0187-2045
Diltiazem hydrochloride 120 mg/1 · Tablet, Extended release · Oral · Bausch Health US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-2045-30 | 00187204530 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2045-30)Marketed from Dec 25, 2010 | |
| 0187-2045-90 | 00187204590 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2045-90)Marketed from Dec 25, 2010 |
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)
- Cardizem LA
- Generic name (nonproprietary)
- diltiazem hydrochloride
- Active ingredients
- Diltiazem hydrochloride — 120 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Bausch Health US LLCNDC labeler code 0187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021392
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 0187-2045_1771fff3-92c3-48ee-b786-5d6d7c6e6628SPL ID 1771fff3-92c3-48ee-b786-5d6d7c6e6628SPL set ID 3e180dc7-c871-4efc-8755-cae882976c8dRxCUI 830874, 830876, 830877, 830878, 830879, 830880, 830882, 830883, 830897, 830898, 830900, 830902UNII OLH94387TEUPC 0301872045909, 0301872047903
- 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
N400187204530followed by a unit qualifier and the quantityPackage 00187-2045-30. 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)
CARDIZEM LA 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 CARDIZEM ® LA is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled tri…
Excerpt only. Read the full label for complete information.
About NDC 0187-2045
- What is NDC 0187-2045?
- 0187-2045 is the product NDC for Cardizem LA (diltiazem hydrochloride), Diltiazem hydrochloride 120 mg/1 tablet, extended release, listed with the FDA by Bausch Health US LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cardizem LA (Diltiazem Hydrochloride).
- What is the active ingredient?
- Diltiazem hydrochloride.
- Who is the labeler?
- Bausch Health US LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cardizem LA?
- 5 other product NDCs are listed under this name. See all Cardizem LA NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cardizem LA products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cardizem LAdiltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Tablet, Extended releaseOral | Bausch Health US LLC | 0187-2046 | 00187-2046-3000187-2046-90 |
| Cardizem LAdiltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Tablet, Extended releaseOral | Bausch Health US LLC | 0187-2047 | 00187-2047-3000187-2047-90 |
| Cardizem LAdiltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Bausch Health US LLC | 0187-2048 | 00187-2048-3000187-2048-90 |
| Cardizem LAdiltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Tablet, Extended releaseOral | Bausch Health US LLC | 0187-2049 | 00187-2049-3000187-2049-90 |
| Cardizem LAdiltiazem hydrochloride | Diltiazem hydrochloride 420 mg/1 | Tablet, Extended releaseOral | Bausch Health US LLC | 0187-2050 | 00187-2050-3000187-2050-90 |
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 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 |
| Cardizem LAdiltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Tablet, Extended releaseOral | Bausch Health US LLC | 0187-2049 |
| Diltiazem Hydrochloridediltiazem hydrochloride extended-release tablets | Diltiazem hydrochloride 180 mg/1 | Tablet, Extended releaseOral | Oceanside Pharmaceuticals | 68682-705 |
| Diltiazem Hydrochloridediltiazem hydrochloride extended-release tablets | Diltiazem hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Oceanside Pharmaceuticals | 68682-704 |
| Cardizem LAdiltiazem hydrochloride | Diltiazem hydrochloride 420 mg/1 | Tablet, Extended releaseOral | Bausch Health US LLC | 0187-2050 |
| Diltiazem Hydrochloridediltiazem hydrochloride extended-release tablets | Diltiazem hydrochloride 420 mg/1 | Tablet, Extended releaseOral | Oceanside Pharmaceuticals | 68682-709 |
| 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 360 mg/1 | Tablet, Extended releaseOral | Oceanside Pharmaceuticals | 68682-708 |