Prescription drug · NDA
Cardizem CD (Diltiazem hydrochloride) NDC 0187-0798
Diltiazem hydrochloride 300 mg/1 · Capsule, Coated, Extended release · Oral · Bausch Health US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-0798-30 | 00187079830 | 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0798-30)Marketed from Apr 11, 2001 | |
| 0187-0798-42 | 00187079842 | 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0798-42)Marketed from Apr 11, 2001 |
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 CD
- Generic name (nonproprietary)
- diltiazem hydrochloride
- Active ingredients
- Diltiazem hydrochloride — 300 mg/1
- Dosage form
- Capsule, Coated, Extended release
- Route
- Oral
- Labeler
- Bausch Health US LLCNDC labeler code 0187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020062
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 0187-0798_bb4d403f-465f-45df-b988-8e656d333f69SPL ID bb4d403f-465f-45df-b988-8e656d333f69SPL set ID 1042fa13-e6af-46b9-8008-6c941f0978b1RxCUI 830795, 830798, 830801, 830803, 830837, 830839, 830845, 830847, 830861, 830863UNII OLH94387TEUPC 0301870796421
- 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
N400187079830followed by a unit qualifier and the quantityPackage 00187-0798-30. 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)
INDICATIONS AND USAGE CARDIZEM CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. CARDIZEM CD is indicated for the management of chronic stable angina and angina due to coronary artery spasm.
Excerpt only. Read the full label for complete information.
About NDC 0187-0798
- What is NDC 0187-0798?
- 0187-0798 is the product NDC for Cardizem CD (diltiazem hydrochloride), Diltiazem hydrochloride 300 mg/1 capsule, coated, 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 CD (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 CD?
- 4 other product NDCs are listed under this name. See all Cardizem CD NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cardizem CD 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 CDdiltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Coated, Extended releaseOral | Bausch Health US LLC | 0187-0795 | 00187-0795-3000187-0795-42 |
| Cardizem CDdiltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Coated, Extended releaseOral | Bausch Health US LLC | 0187-0796 | 00187-0796-3000187-0796-42 |
| Cardizem CDdiltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Coated, Extended releaseOral | Bausch Health US LLC | 0187-0797 | 00187-0797-3000187-0797-42 |
| Cardizem CDdiltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Coated, Extended releaseOral | Bausch Health US LLC | 0187-0799 | 00187-0799-42 |
Other NDCs under NDA 020062
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 CDdiltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Coated, Extended releaseOral | Bausch Health US LLC | 0187-0795 |
| Cardizem CDdiltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Coated, Extended releaseOral | Bausch Health US LLC | 0187-0796 |
| Cardizem CDdiltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Coated, Extended releaseOral | Bausch Health US LLC | 0187-0797 |
| Cardizem CDdiltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Coated, Extended releaseOral | Bausch Health US LLC | 0187-0799 |