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United States · US · US:75834-194_29803114-1d00-4e06-9a14-b75895c85f5a
GLYCOPYRROLATE
Orange BookUNIISPLATC A03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNivagen Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11758341942525 VIAL, SINGLE-DOSE in 1 CARTON (75834-194-25) / 2 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
V92SO9WP2I
GLYCOPYRROLATE
RxCUI 4955
Orange Book
A212591
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": "75834-194_29803114-1d00-4e06-9a14-b75895c85f5a",
"productndc": "75834-194",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "212591",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.2MG/ML",
"product_no": "001",
"approval_date": "Oct 13, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLYCOPYRROLATE",
"proprietary_name": "GLYCOPYRROLATE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA212591",
"marketing_category": "ANDA",
"nonproprietary_name": "glycopyrrolate",
"start_marketing_date": "20211025",
"active_numerator_strength": ".2"
}Related drugs
Other records sharing ATC code A03AB02.
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