Prescription drug · ANDA
Diltiazem Hydrochloride NDC 50228-484
Diltiazem hydrochloride 120 mg/1 · Tablet · Oral · ScieGen Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-484-01 | 50228048401 | 100 TABLET in 1 BOTTLE (50228-484-01)Marketed from Sep 26, 2022 | |
| 50228-484-05 | 50228048405 | 500 TABLET in 1 BOTTLE (50228-484-05)Marketed from Sep 26, 2022 | |
| 50228-484-30 | 50228048430 | 30 TABLET in 1 BOTTLE (50228-484-30)Marketed from Sep 26, 2022 |
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 — 120 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals, Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216521
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 50228-484_31a9f85e-b3f0-4b39-a133-8d4324df2affSPL ID 31a9f85e-b3f0-4b39-a133-8d4324df2affSPL set ID 196fc367-330e-4d15-b1d6-084ad3f97ae7RxCUI 831054, 831102, 831103, 833217UNII OLH94387TEUPC 0350228484015, 0350228481052, 0350228484053, 0350228482059, 0350228483018, 0350228482011, 0350228483056, 0350228481014
- 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
N450228048401followed by a unit qualifier and the quantityPackage 50228-0484-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216521
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 30 mg/1 | TabletOral | Coupler LLC | 67046-1492 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2373 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3135 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-024 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | TabletOral | A-S Medication Solutions | 50090-7401 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 30 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-036 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | TabletOral | Coupler LLC | 67046-1560 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 30 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc | 50228-481 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc | 50228-482 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc | 50228-483 |