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United States · US · US:80056-160_feae0733-6244-4791-b717-581bde769f02
Glycate
Orange BookUNIISPLATC A03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIntra-Sana Laboratories
CountryUS (United States)
ATC codeA03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118005616010100 TABLET in 1 BOTTLE (80056-160-10)
Annotations
UNII (FDA Substance ID)
V92SO9WP2I
GLYCOPYRROLATE
RxCUI 4955
Orange Book
A091522
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": {
"830ba1be-bef3-417c-a915-964cc6005b92": {
"match": "brand_token",
"title": "GLYCATE (GLYCOPYRROLATE) TABLET [INTRA-SANA LABORATORIES]",
"spl_version": "4",
"published_date": "2026-01-12"
}
},
"productid": "80056-160_feae0733-6244-4791-b717-581bde769f02",
"productndc": "80056-160",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "091522",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "1.5MG",
"product_no": "001",
"approval_date": "Mar 12, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLYCOPYRROLATE",
"proprietary_name": "Glycate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091522",
"marketing_category": "ANDA",
"nonproprietary_name": "Glycopyrrolate",
"start_marketing_date": "20220401",
"active_numerator_strength": "1.5"
}Related drugs
Other records sharing ATC code A03AB02.
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