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United States · US · US:68083-534_ffd998aa-4c6f-4463-b77c-9dc2e722b948

Chlorpromazine hydrochloride

Orange BookUNIISPLATC N05AA01

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

Identification

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

Packs · 1

  • ndc11
    6808353425
    25 VIAL in 1 CARTON (68083-534-25) / 2 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
9WP59609J6
CHLORPROMAZINE HYDROCHLORIDE
RxCUI 104728
Orange Book
A216911
AP
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": "INTRAMUSCULAR",
  "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": "68083-534_ffd998aa-4c6f-4463-b77c-9dc2e722b948",
  "productndc": "68083-534",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216911",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "25MG/ML",
        "product_no": "001",
        "approval_date": "Oct 4, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLORPROMAZINE HYDROCHLORIDE",
  "proprietary_name": "Chlorpromazine hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216911",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Chlorpromazine hydrochloride",
  "start_marketing_date": "20241004",
  "active_numerator_strength": "25"
}

Related drugs

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