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NDC 00409-0125-25 Labetalol Hydrochloride 5 mg/mL Details
Labetalol Hydrochloride 5 mg/mL
Labetalol Hydrochloride is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hospira, Inc.. The primary component is LABETALOL HYDROCHLORIDE.
Product Information
| NDC | 00409-0125 |
|---|---|
| Product ID | 0409-0125_2ea8704a-ff7d-4724-9e92-751141d9e43f |
| Associated GPIs | |
| GCN Sequence Number | 005097 |
| GCN Sequence Number Description | labetalol HCl VIAL 5 MG/ML INTRAVEN |
| HIC3 | J7A |
| HIC3 Description | ALPHA/BETA-ADRENERGIC BLOCKING AGENTS |
| GCN | 18990 |
| HICL Sequence Number | 002095 |
| HICL Sequence Number Description | LABETALOL HCL |
| Brand/Generic | Generic |
| Proprietary Name | Labetalol Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Labetalol Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/mL |
| Substance Name | LABETALOL HYDROCHLORIDE |
| Labeler Name | Hospira, Inc. |
| Pharmaceutical Class | Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075240 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00409-0125-25 (00409012525)
| NDC Package Code | 0409-0125-25 |
|---|---|
| Billing NDC | 00409012525 |
| Package | 25 VIAL, MULTI-DOSE in 1 TRAY (0409-0125-25) / 20 mL in 1 VIAL, MULTI-DOSE (0409-0125-01) |
| Marketing Start Date | 2023-08-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |