Hydroxyzine hydrochloride

Orange BookSPLATC N05BB01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeN05BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7642088201
100 TABLET in 1 BOTTLE (76420-882-01)
ndc11
7642088205
500 TABLET in 1 BOTTLE (76420-882-05)
ndc11
7642088210
1000 TABLET in 1 BOTTLE (76420-882-10)
ndc11
7642088230
30 TABLET in 1 BOTTLE (76420-882-30)
ndc11
7642088260
60 TABLET in 1 BOTTLE (76420-882-60)
ndc11
7642088290
90 TABLET in 1 BOTTLE (76420-882-90)

Annotations

Orange Book

A204279

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "ORAL",
  "spl_meta": {
    "4cd84205-6a33-db48-e063-6394a90a9182": {
      "match": "brand_token",
      "title": "HYDROXYZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "76420-882_2979cc3d-941b-4936-e063-6394a90ab8f8",
  "productndc": "76420-882",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204279",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Aug 20, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Aug 20, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Aug 20, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROXYZINE DIHYDROCHLORIDE",
  "proprietary_name": "Hydroxyzine hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204279",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydroxyzine hydrochloride",
  "start_marketing_date": "20140820",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code N05BB01.

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