Diltiazem Hydrochloride
- Product NDC
- 46708-815
- 11-digit product format
- 467080815
- Labeler code
- 46708
- Product ID
- 46708-815_61b9ca82-7d41-4f49-b4a0-549c9473c447
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA218587
- Marketing category
- ANDA
- Marketing start
- 2024-10-28
- 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 |
|---|
| 46708-815-31 | 46708081531 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-815-31) | 2024-10-28 | No | No | Historical |
| 46708-815-71 | 46708081571 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-815-71) | 2024-10-28 | No | No | Historical |
| 46708-815-91 | 46708081591 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-815-91) | 2024-10-28 | No | No | Historical |