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NDC 36000-0324-02 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 Baxter Healthcare Corporation. The primary component is LABETALOL HYDROCHLORIDE.
Product Information
| NDC | 36000-0324 |
|---|---|
| Product ID | 36000-324_26ae2de7-7634-4eb9-8584-8f0613357778 |
| Associated GPIs | 33300010102005 |
| 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 | Baxter Healthcare Corporation |
| Pharmaceutical Class | Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076051 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 36000-0324-02 (36000032402)
| NDC Package Code | 36000-324-02 |
|---|---|
| Billing NDC | 36000032402 |
| Package | 1 VIAL in 1 CARTON (36000-324-02) / 40 mL in 1 VIAL (36000-324-01) |
| Marketing Start Date | 2021-01-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |