Bethanechol Chloride

Orange BookUNIISPLATC N07AB02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeN07AB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6516257210
100 TABLET in 1 BOTTLE (65162-572-10)
ndc11
6516257211
1000 TABLET in 1 BOTTLE (65162-572-11)
ndc11
6516257250
500 TABLET in 1 BOTTLE (65162-572-50)

Annotations

UNII (FDA Substance ID)

H4QBZ2LO84

BETHANECHOL CHLORIDE

RxCUI 47088

Orange Book

A040855

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": "65162-572_20630162-d16b-4671-a94a-618acea32787",
  "productndc": "65162-572",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040855",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Nov 21, 2007"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Nov 21, 2007"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "25MG",
        "product_no": "003",
        "approval_date": "Nov 21, 2007"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "50MG",
        "product_no": "004",
        "approval_date": "Nov 21, 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": "ANDA040855",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bethanechol Chloride",
  "start_marketing_date": "20071121",
  "active_numerator_strength": "10"
}

Related drugs

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