Prescription drug · ANDA
Diltiazem Hydrochloride NDC 0615-8032
Diltiazem hydrochloride 30 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8032-39 | 00615803239 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8032-39)Marketed from May 10, 2016 |
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)
- Diltiazem Hydrochloride
- Generic name (nonproprietary)
- diltiazem hydrochloride
- Active ingredients
- Diltiazem hydrochloride — 30 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074185
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 0615-8032_f396d205-71ac-4e1a-b989-a6a2c2da9677SPL ID f396d205-71ac-4e1a-b989-a6a2c2da9677SPL set ID 74620be9-5120-491a-a171-e50612c06541RxCUI 831103, 833217UNII 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
N400615803239followed by a unit qualifier and the quantityPackage 00615-8032-39. 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 USP 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 074185
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 60 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0451 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-020 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 30 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3659 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 30 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-0318 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-0319 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-0320 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-0321 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-769 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 30 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-717 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-728 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8033 |