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United States · US · US:82983-428_80036e14-8ef8-4d3e-a6c5-4bfca592dd79
Glycopyrrolate Oral Solution
Orange BookUNIISPLATC A03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAJENAT PHARMACEUTICALS LLC
CountryUS (United States)
ATC codeA03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1182983428471 BOTTLE in 1 BOTTLE (82983-428-47) / 473 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
V92SO9WP2I
GLYCOPYRROLATE
RxCUI 4955
Orange Book
A219267
AA
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": "82983-428_80036e14-8ef8-4d3e-a6c5-4bfca592dd79",
"productndc": "82983-428",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "219267",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "1MG/5ML",
"product_no": "001",
"approval_date": "Oct 27, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLYCOPYRROLATE",
"proprietary_name": "Glycopyrrolate Oral Solution",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA219267",
"marketing_category": "ANDA",
"nonproprietary_name": "Glycopyrrolate",
"start_marketing_date": "20251212",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code A03AB02.
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