diltiazem hydrochloride
- Product NDC
- 0615-8379
- 11-digit product format
- 006158379
- Labeler code
- 0615
- Product ID
- 0615-8379_72f92a1f-d8d6-494e-a8e9-875ca4bf4b50
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diltiazem hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA208783
- Marketing category
- ANDA
- Marketing start
- 2019-06-14
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 120 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| OLH94387TE | DILTIAZEM HYDROCHLORIDE | 33286-22-5 | DILTIAZEM HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8379-39 | 00615837939 | 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8379-39) | 2021-02-09 | No | No | Historical |