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United States · US · US:59651-570_22ddf306-4ee5-4358-900d-1e76b14bf237

Chlorpromazine Hydrochloride

Orange BookUNIISPLATC N05AA01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN05AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5965157001
    100 TABLET in 1 BOTTLE (59651-570-01)
  • ndc11
    5965157099
    1000 TABLET in 1 BOTTLE (59651-570-99)

Annotations

UNII (FDA Substance ID)
9WP59609J6
CHLORPROMAZINE HYDROCHLORIDE
RxCUI 104728
Orange Book
A216788
ABABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9WP59609J6",
    "rxcui": "104728",
    "inchikey": "FBSMERQALIEGJT-UHFFFAOYSA-N",
    "display_name": "CHLORPROMAZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "85ab0b93-c716-4889-87db-9e76e75df7c7": {
      "match": "brand_token",
      "title": "CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [AMERICAN HEALTH PACKAGING]",
      "spl_version": "2",
      "published_date": "2026-05-28"
    }
  },
  "productid": "59651-570_22ddf306-4ee5-4358-900d-1e76b14bf237",
  "productndc": "59651-570",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216788",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Apr 25, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Apr 25, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Apr 25, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Apr 25, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "005",
        "approval_date": "Apr 25, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLORPROMAZINE HYDROCHLORIDE",
  "proprietary_name": "Chlorpromazine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216788",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Chlorpromazine Hydrochloride",
  "start_marketing_date": "20250425",
  "active_numerator_strength": "100"
}

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