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United States · US · US:76385-101_10a9a368-4ddc-4ffc-abfb-605c98fe1d97

METHSCOPOLAMINE BROMIDE

Orange BookUNIISPLATC A03BB03

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

Identification

ManufacturerUnichem Pharmaceuticals (USA), Inc.
CountryUS (United States)
ATC codeA03BB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7638510160
    60 TABLET in 1 BOTTLE (76385-101-60)

Annotations

UNII (FDA Substance ID)
RTN51LK7WL
METHSCOPOLAMINE BROMIDE
RxCUI 56092
Orange Book
A200602
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": "76385-101_10a9a368-4ddc-4ffc-abfb-605c98fe1d97",
  "productndc": "76385-101",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "200602",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Sep 24, 2012"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Sep 24, 2012"
      }
    ],
    "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": "ANDA200602",
  "marketing_category": "ANDA",
  "nonproprietary_name": "methscopolamine bromide",
  "start_marketing_date": "20131001",
  "active_numerator_strength": "5"
}

Related drugs

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