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United States · US · US:16571-744_9f8d9c4c-f326-4784-8ea4-f791613077f7
Glycopyrrolate
Orange BookUNIISPLATC A03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeA03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11165717440330 TABLET in 1 CONTAINER (16571-744-03)
- ndc11165717440990 TABLET in 1 CONTAINER (16571-744-09)
Annotations
UNII (FDA Substance ID)
V92SO9WP2I
GLYCOPYRROLATE
RxCUI 4955
Orange Book
N012827
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": "16571-744_9f8d9c4c-f326-4784-8ea4-f791613077f7",
"productndc": "16571-744",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "012827",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AA",
"strength": "1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AA",
"strength": "2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"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/1",
"application_number": "NDA012827",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Glycopyrrolate",
"start_marketing_date": "20201006",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code A03AB02.
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