Hydroxyzine hydrochloride

Orange BookSPLATC 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
6362918561
30 TABLET, FILM COATED in 1 BOTTLE (63629-1856-1)
ndc11
6362918562
60 TABLET, FILM COATED in 1 BOTTLE (63629-1856-2)
ndc11
6362918563
20 TABLET, FILM COATED in 1 BOTTLE (63629-1856-3)
ndc11
6362918564
100 TABLET, FILM COATED in 1 BOTTLE (63629-1856-4)
ndc11
6362918565
15 TABLET, FILM COATED in 1 BOTTLE (63629-1856-5)
ndc11
6362918566
90 TABLET, FILM COATED in 1 BOTTLE (63629-1856-6)
ndc11
6362918567
19 TABLET, FILM COATED in 1 BOTTLE (63629-1856-7)
ndc11
6362918568
10 TABLET, FILM COATED in 1 BOTTLE (63629-1856-8)

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": "63629-1856_9efda664-6143-4427-9290-60c6abf0ec0b",
  "productndc": "63629-1856",
  "dosage_form": "TABLET, FILM COATED",
  "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.

Access this data programmatically

Query Hydroxyzine hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs