Prescription drug · ANDA
Diltiazem Hydrochloride NDC 50228-498
Diltiazem hydrochloride 300 mg/1 · Tablet, Extended release · Oral · ScieGen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-498-05 | 50228049805 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-498-05)Marketed from Apr 6, 2023 | |
| 50228-498-30 | 50228049830 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-498-30)Marketed from Apr 6, 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)
- Diltiazem Hydrochloride
- Generic name (nonproprietary)
- diltiazem hydrochloride
- Active ingredients
- Diltiazem hydrochloride — 300 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216327
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 50228-498_2fc25445-56c7-4c39-ac18-32cc1023e7c2SPL ID 2fc25445-56c7-4c39-ac18-32cc1023e7c2SPL set ID 1ca03c9e-edc8-4c7f-89ee-f2346ea8c067RxCUI 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
N450228049805followed by a unit qualifier and the quantityPackage 50228-0498-05. 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 Tablet 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 and myo…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216327
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 |
|---|---|---|---|---|
| Diltiazem Hydrochloride | Diltiazem hydrochloride 420 mg/1 | Tablet, Extended releaseOral | ScieGen Pharmaceuticals, Inc. | 50228-500 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Cipla USA, Inc. | 69097-992 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 180 mg/1 | Tablet, Extended releaseOral | Cipla USA, Inc. | 69097-993 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 420 mg/1 | Tablet, Extended releaseOral | Cipla USA, Inc. | 69097-997 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 240 mg/1 | Tablet, Extended releaseOral | Cipla USA, Inc. | 69097-994 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Cipla USA, Inc. | 69097-995 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 360 mg/1 | Tablet, Extended releaseOral | Cipla USA, Inc. | 69097-996 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Tablet, Extended releaseOral | ScieGen Pharmaceuticals, Inc. | 50228-495 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 360 mg/1 | Tablet, Extended releaseOral | ScieGen Pharmaceuticals, Inc. | 50228-499 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 180 mg/1 | Tablet, Extended releaseOral | ScieGen Pharmaceuticals, Inc. | 50228-496 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 240 mg/1 | Tablet, Extended releaseOral | ScieGen Pharmaceuticals, Inc. | 50228-497 |