Bethanechol Chloride

Orange BookUNIISPLATC N07AB02

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

Identification

ManufacturerHeritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.

CountryUS (United States)

ATC codeN07AB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2315593501
100 TABLET in 1 BOTTLE (23155-935-01)

Annotations

UNII (FDA Substance ID)

H4QBZ2LO84

BETHANECHOL CHLORIDE

RxCUI 47088

Orange Book

A091256

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": "23155-935_ffe9461d-3417-4da1-af45-185d7b3bd2aa",
  "productndc": "23155-935",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091256",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 4, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "May 4, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "25MG",
        "product_no": "003",
        "approval_date": "May 4, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "50MG",
        "product_no": "004",
        "approval_date": "May 4, 2010"
      }
    ],
    "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": "ANDA091256",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bethanechol Chloride",
  "start_marketing_date": "20250630",
  "active_numerator_strength": "10"
}

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