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NDC 00517-5602-25 Hydroxyzine Hydrochloride 50 mg/mL Details
Hydroxyzine Hydrochloride 50 mg/mL
Hydroxyzine Hydrochloride is a INTRAMUSCULAR INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by American Regent, Inc.. The primary component is HYDROXYZINE DIHYDROCHLORIDE.
Product Information
| NDC | 00517-5602 |
|---|---|
| Product ID | 0517-5602_6d7bbb1a-0613-4ed8-8896-40c07c2b64df |
| Associated GPIs | 57200040102010 |
| GCN Sequence Number | 003724 |
| GCN Sequence Number Description | hydroxyzine HCl VIAL 50 MG/ML INTRAMUSC |
| HIC3 | Z2P |
| HIC3 Description | ANTIHISTAMINES - 1ST GENERATION |
| GCN | 13882 |
| HICL Sequence Number | 001608 |
| HICL Sequence Number Description | HYDROXYZINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Hydroxyzine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Hydroxyzine Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | HYDROXYZINE DIHYDROCHLORIDE |
| Labeler Name | American Regent, Inc. |
| Pharmaceutical Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA087408 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00517-5602-25 (00517560225)
| NDC Package Code | 0517-5602-25 |
|---|---|
| Billing NDC | 00517560225 |
| Package | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-5602-25) / 2 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 1990-09-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |