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United States · US · US:0641-6212_9cafddcc-42f5-486b-9a17-46d75bd6227b
Glycopyrrolate
Orange BookUNIISPLATC A03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11064162121010 SYRINGE, GLASS in 1 CARTON (0641-6212-10) / 1 mL in 1 SYRINGE, GLASS (0641-6212-01)
Annotations
UNII (FDA Substance ID)
V92SO9WP2I
GLYCOPYRROLATE
RxCUI 4955
Orange Book
N017558
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": "0641-6212_9cafddcc-42f5-486b-9a17-46d75bd6227b",
"productndc": "0641-6212",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "017558",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "0.2MG/ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLYCOPYRROLATE",
"proprietary_name": "Glycopyrrolate",
"active_ingred_unit": "mg/mL",
"application_number": "NDA017558",
"marketing_category": "NDA",
"nonproprietary_name": "Glycopyrrolate",
"start_marketing_date": "20250828",
"active_numerator_strength": ".2"
}Related drugs
Other records sharing ATC code A03AB02.
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