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NDC 72789-0216-04 Hydroxyzine Hydrochloride 25 mg/1 Details
Hydroxyzine Hydrochloride 25 mg/1
Hydroxyzine Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, Inc.. The primary component is HYDROXYZINE DIHYDROCHLORIDE.
Product Information
NDC | 72789-0216 |
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Product ID | 72789-216_0322ef5c-632f-d1e6-e063-6294a90a417a |
Associated GPIs | 57200040100310 |
GCN Sequence Number | 003728 |
GCN Sequence Number Description | hydroxyzine HCl TABLET 25 MG ORAL |
HIC3 | Z2P |
HIC3 Description | ANTIHISTAMINES - 1ST GENERATION |
GCN | 13943 |
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 | 25 |
Active Ingredient Units | mg/1 |
Substance Name | HYDROXYZINE DIHYDROCHLORIDE |
Labeler Name | PD-Rx Pharmaceuticals, Inc. |
Pharmaceutical Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA088618 |
Listing Certified Through | 2024-12-31 |
Package
NDC 72789-0216-04 (72789021604)
NDC Package Code | 72789-216-04 |
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Billing NDC | 72789021604 |
Package | 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-04) |
Marketing Start Date | 2023-08-17 |
NDC Exclude Flag | N |
Pricing Information | N/A |