hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: puracap laboratories llc dba blu pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler puracap laboratories llc dba blu pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/1

Manufacturer
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS

Identifiers & Regulatory

Product NDC 24658-781
Product ID 24658-781_384448bf-baa4-482b-91cd-585b03c62907
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040604
Listing Expiration 2027-12-31
Marketing Start 2021-07-21

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24658781
Hyphenated Format 24658-781

Supplemental Identifiers

RxCUI
995218 995258 995281
UPC
0324658782102 0324658781105 0324658783109
UNII
76755771U3

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hydroxyzine hydrochloride (source: ndc)
Generic Name hydroxyzine hydrochloride (source: ndc)
Application Number ANDA040604 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (24658-781-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (24658-781-10)
source: ndc

Packages (2)

24658-781-05 500 TABLET, FILM COATED in 1 BOTTLE (24658-781-05) 24658-781-10 1000 TABLET, FILM COATED in 1 BOTTLE (24658-781-10)

Ingredients (1)

hydroxyzine dihydrochloride (10 mg/1)

Linked Drug Pages (1)

Hydroxyzine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "384448bf-baa4-482b-91cd-585b03c62907", "openfda": {"upc": ["0324658782102", "0324658781105", "0324658783109"], "unii": ["76755771U3"], "rxcui": ["995218", "995258", "995281"], "spl_set_id": ["19fe26a9-eb1a-4c5b-a5e4-65223ee56ad1"], "manufacturer_name": ["PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (24658-781-05)", "package_ndc": "24658-781-05", "marketing_start_date": "20241024"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (24658-781-10)", "package_ndc": "24658-781-10", "marketing_start_date": "20210721"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "24658-781_384448bf-baa4-482b-91cd-585b03c62907", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "24658-781", "generic_name": "Hydroxyzine Hydrochloride", "labeler_name": "PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA040604", "marketing_category": "ANDA", "marketing_start_date": "20210721", "listing_expiration_date": "20271231"}