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United States · US · US:68083-379_92de5a0f-2918-4f66-a087-535c2dd0b3bd
Glycopyrrolate
Orange BookUNIISPLATC A03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeA03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680833791010 VIAL in 1 CARTON (68083-379-10) / 20 mL in 1 VIAL (68083-379-01)
Annotations
UNII (FDA Substance ID)
V92SO9WP2I
GLYCOPYRROLATE
RxCUI 4955
Orange Book
A212612
AP
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": "INTRAMUSCULAR; INTRAVENOUS",
"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": "68083-379_92de5a0f-2918-4f66-a087-535c2dd0b3bd",
"productndc": "68083-379",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "212612",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.2MG/ML",
"product_no": "001",
"approval_date": "Sep 30, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLYCOPYRROLATE",
"proprietary_name": "Glycopyrrolate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA212612",
"marketing_category": "ANDA",
"nonproprietary_name": "Glycopyrrolate",
"start_marketing_date": "20191009",
"active_numerator_strength": ".2"
}Related drugs
Other records sharing ATC code A03AB02.
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