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United States · US · US:70518-4597_4dec6029-9801-aee7-e063-6294a90af79c
Glycopyrrolate
Orange BookUNIISPLATC A03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeA03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117051845970100 POUCH in 1 BOX (70518-4597-0) / 1 TABLET in 1 POUCH (70518-4597-1)
Annotations
UNII (FDA Substance ID)
V92SO9WP2I
GLYCOPYRROLATE
RxCUI 4955
Orange Book
A207201
AAAA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "V92SO9WP2I",
"rxcui": "4955",
"inchikey": "VPNYRYCIDCJBOM-QQTWVUFVSA-M;VPNYRYCIDCJBOM-POCMBTLOSA-M",
"display_name": "GLYCOPYRROLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"ec15e70c-8473-469a-9f07-ea668783fa07": {
"match": "brand_token",
"title": "GLYCOPYRROLATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "9",
"published_date": "2026-06-01"
}
},
"productid": "70518-4597_4dec6029-9801-aee7-e063-6294a90af79c",
"productndc": "70518-4597",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207201",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "1MG",
"product_no": "001",
"approval_date": "Jan 3, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "2MG",
"product_no": "002",
"approval_date": "Jan 3, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLYCOPYRROLATE",
"proprietary_name": "Glycopyrrolate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207201",
"marketing_category": "ANDA",
"nonproprietary_name": "Glycopyrrolate",
"start_marketing_date": "20260325",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code A03AB02.
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