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United States · US · US:62135-755_0f8f30ff-cd99-1911-e063-6394a90ad218

Bethanechol Chloride

Orange BookUNIISPLATC N07AB02

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

Identification

ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeN07AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6213575590
    90 TABLET in 1 BOTTLE (62135-755-90)

Annotations

UNII (FDA Substance ID)
H4QBZ2LO84
BETHANECHOL CHLORIDE
RxCUI 47088
Orange Book
A040728
AAAAAAAA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "H4QBZ2LO84",
    "rxcui": "47088",
    "inchikey": "XXRMYXBSBOVVBH-UHFFFAOYSA-N",
    "display_name": "BETHANECHOL CHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "16523451-cd3d-4c10-be06-d59a6f12ac68": {
      "match": "brand_token",
      "title": "BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]",
      "spl_version": "5",
      "published_date": "2026-02-12"
    }
  },
  "productid": "62135-755_0f8f30ff-cd99-1911-e063-6394a90ad218",
  "productndc": "62135-755",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040728",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Oct 26, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Oct 26, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Oct 26, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "25MG",
        "product_no": "004",
        "approval_date": "Oct 26, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BETHANECHOL CHLORIDE",
  "proprietary_name": "Bethanechol Chloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040728",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bethanechol Chloride",
  "start_marketing_date": "20071026",
  "active_numerator_strength": "5"
}

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