HYDROXYZINE HYDROCHLORIDE

Orange BookUNIISPLATC N05BB01

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN05BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7133526361
30 TABLET, FILM COATED in 1 BOTTLE (71335-2636-1)
ndc11
7133526362
100 TABLET, FILM COATED in 1 BOTTLE (71335-2636-2)
ndc11
7133526363
20 TABLET, FILM COATED in 1 BOTTLE (71335-2636-3)
ndc11
7133526364
90 TABLET, FILM COATED in 1 BOTTLE (71335-2636-4)
ndc11
7133526365
15 TABLET, FILM COATED in 1 BOTTLE (71335-2636-5)
ndc11
7133526366
60 TABLET, FILM COATED in 1 BOTTLE (71335-2636-6)
ndc11
7133526367
120 TABLET, FILM COATED in 1 BOTTLE (71335-2636-7)
ndc11
7133526368
10 TABLET, FILM COATED in 1 BOTTLE (71335-2636-8)

Annotations

UNII (FDA Substance ID)

76755771U3

HYDROXYZINE HYDROCHLORIDE

RxCUI 154987

Orange Book

A217652

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "76755771U3",
    "rxcui": "154987",
    "inchikey": "ANOMHKZSQFYSBR-UHFFFAOYSA-N",
    "display_name": "HYDROXYZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "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": "71335-2636_f3f81841-db62-4a69-b56c-466088cfa950",
  "productndc": "71335-2636",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "217652",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Aug 17, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Aug 17, 2023"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Aug 17, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROXYZINE HYDROCHLORIDE",
  "proprietary_name": "HYDROXYZINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217652",
  "marketing_category": "ANDA",
  "nonproprietary_name": "hydroxyzine hydrochloride",
  "start_marketing_date": "20230822",
  "active_numerator_strength": "10"
}

Related drugs

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