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United States · US · US:68462-861_440a4208-83cc-4ffa-952c-d9c0745c342a

Chlorpromazine Hydrochloride

Orange BookUNIISPLATC N05AA01

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeN05AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6846286101
    100 TABLET, FILM COATED in 1 BOTTLE (68462-861-01)
  • ndc11
    6846286110
    1000 TABLET, FILM COATED in 1 BOTTLE (68462-861-10)

Annotations

UNII (FDA Substance ID)
9WP59609J6
CHLORPROMAZINE HYDROCHLORIDE
RxCUI 104728
Orange Book
A212144
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": "68462-861_440a4208-83cc-4ffa-952c-d9c0745c342a",
  "productndc": "68462-861",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "212144",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Mar 23, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Mar 23, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Mar 23, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Mar 23, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "005",
        "approval_date": "Mar 23, 2021"
      }
    ],
    "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": "ANDA212144",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Chlorpromazine Hydrochloride",
  "start_marketing_date": "20210323",
  "active_numerator_strength": "10"
}

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