Diltiazem Hydrochloride
- Product NDC
- 84549-319
- 11-digit product format
- 845490319
- Labeler code
- 84549
- Product ID
- 84549-319_3f2942d7-f4d1-2d77-e063-6294a90a74ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diltiazem hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- ProPharma Distribution
- Application
- ANDA074617
- Marketing category
- ANDA
- Marketing start
- 2024-06-01
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 5 mg/mL
- 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 | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OLH94387TE |
| Rxcui | 1791229 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84549-319-05 | Diltiazem Hydrochloride | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84549-319-05 | 84549031905 | 5 mL in 1 VIAL (84549-319-05) | 5 ml | 2025-09-18 | No | No | Historical |