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NDC 00641-9217-10 Diltiazem Hydrochloride 5 mg/mL Details
Diltiazem Hydrochloride 5 mg/mL
Diltiazem Hydrochloride is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is DILTIAZEM HYDROCHLORIDE.
Product Information
| NDC | 00641-9217 |
|---|---|
| Product ID | 0641-9217_0e067aab-ea5a-48da-8125-c09977b656d2 |
| Associated GPIs | 34000010102025 |
| GCN Sequence Number | 016424 |
| GCN Sequence Number Description | diltiazem HCl VIAL 5 MG/ML INTRAVEN |
| HIC3 | A9A |
| HIC3 Description | CALCIUM CHANNEL BLOCKING AGENTS |
| GCN | 02641 |
| HICL Sequence Number | 000182 |
| HICL Sequence Number Description | DILTIAZEM HCL |
| Brand/Generic | Generic |
| Proprietary Name | Diltiazem Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diltiazem Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/mL |
| Substance Name | DILTIAZEM HYDROCHLORIDE |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078538 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00641-9217-10 (00641921710)
| NDC Package Code | 0641-9217-10 |
|---|---|
| Billing NDC | 00641921710 |
| Package | 10 VIAL in 1 CARTON (0641-9217-10) / 5 mL in 1 VIAL (0641-9217-01) |
| Marketing Start Date | 2008-12-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |