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United States · US · US:72319-029_2ee941f2-7d8c-dd6e-e063-6394a90a0db9

METHSCOPOLAMINE BROMIDE

Orange BookUNIISPLATC A03BB03

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

Identification

Manufactureri3 Pharmaceuticals, LLC
CountryUS (United States)
ATC codeA03BB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7231902904
    100 TABLET in 1 BOTTLE (72319-029-04)
  • ndc11
    7231902906
    1000 TABLET in 1 BOTTLE (72319-029-06)

Annotations

UNII (FDA Substance ID)
RTN51LK7WL
METHSCOPOLAMINE BROMIDE
RxCUI 56092
Orange Book
A216786
AAAA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "RTN51LK7WL",
    "rxcui": "56092",
    "inchikey": "CXYRUNPLKGGUJF-RAFJPFSSSA-M",
    "display_name": "METHSCOPOLAMINE BROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6b8ed187-d378-4c95-80e0-0d3558a7aa95": {
      "match": "brand_token",
      "title": "METHSCOPOLAMINE BROMIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "101",
      "published_date": "2026-03-18"
    }
  },
  "productid": "72319-029_2ee941f2-7d8c-dd6e-e063-6394a90a0db9",
  "productndc": "72319-029",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216786",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Feb 1, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Feb 1, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHSCOPOLAMINE BROMIDE",
  "proprietary_name": "METHSCOPOLAMINE BROMIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216786",
  "marketing_category": "ANDA",
  "nonproprietary_name": "methscopolamine bromide",
  "start_marketing_date": "20241218",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code A03BB03.

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