Diltiazem Hydrochloride
- Product NDC
- 46708-784
- 11-digit product format
- 467080784
- Labeler code
- 46708
- Product ID
- 46708-784_74bab197-f719-48c0-ac84-c0cf0087b45a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA217633
- Marketing category
- ANDA
- Marketing start
- 2025-11-14
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diltiazem Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DILTIAZEM HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OLH94387TE |
| Rxcui | 831054, 831102, 831103, 833217 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-784-31 | Diltiazem Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 46708-784-71 | Diltiazem Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-784-31 | 46708078431 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-784-31) | 2025-11-14 | No | No | Current |
| 46708-784-71 | 46708078471 | 500 TABLET, FILM COATED in 1 BOTTLE (46708-784-71) | 2025-11-14 | No | No | Current |