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NDC 16571-0115-01 HYDROXYZINE HYDROCHLORIDE 50 mg/1 Details
HYDROXYZINE HYDROCHLORIDE 50 mg/1
HYDROXYZINE HYDROCHLORIDE is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Rising Pharma Holdings, Inc.. The primary component is HYDROXYZINE DIHYDROCHLORIDE.
MedlinePlus Drug Summary
Hydroxyzine is used in adults and children to relieve itching caused by allergic skin reactions. It is also used alone or with other medications in adults and children to relieve anxiety and tension. Hydroxyzine is also used along with other medications in adults and children as a sedative before and after general anesthesia for surgery. Hydroxyzine is in a class of medications called antihistamines. It works by blocking the action of histamine a substance in the body that causes allergic symptoms. It also works by decreasing activity in the brain.
Related Packages: 16571-0115-01Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Hydroxyzine
Product Information
| NDC | 16571-0115 |
|---|---|
| Product ID | 16571-115_9ca46d47-3a27-47d8-b2ca-a2f5719a8042 |
| Associated GPIs | |
| GCN Sequence Number | 003729 |
| GCN Sequence Number Description | hydroxyzine HCl TABLET 50 MG ORAL |
| HIC3 | Z2P |
| HIC3 Description | ANTIHISTAMINES - 1ST GENERATION |
| GCN | 13944 |
| 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 | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | HYDROXYZINE DIHYDROCHLORIDE |
| Labeler Name | Rising Pharma Holdings, Inc. |
| Pharmaceutical Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA217652 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 16571-0115-01 (16571011501)
| NDC Package Code | 16571-115-01 |
|---|---|
| Billing NDC | 16571011501 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE (16571-115-01) |
| Marketing Start Date | 2023-08-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |