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United States · US · US:42023-269_a1b07822-805f-4c68-914f-1db1cead480a
PREVDUO
Orange BookUNIISPLATC D11AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEndo USA
CountryUS (United States)
ATC codeD11AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1142023269055 SYRINGE, PLASTIC in 1 CARTON (42023-269-05) / 3 mL in 1 SYRINGE, PLASTIC (42023-269-01)
Annotations
UNII (FDA Substance ID)
V92SO9WP2I
GLYCOPYRROLATE
RxCUI 4955
Orange Book
N216903
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": "INTRAVENOUS",
"spl_meta": {
"dd8ad38f-247b-4948-a13c-8f3a4921b4f1": {
"match": "brand_token",
"title": "PREVDUO (NEOSTIGMINE METHYLSULFATE AND GLYCOPYRROLATE) INJECTION [ENDO USA]",
"spl_version": "2",
"published_date": "2024-10-31"
}
},
"productid": "42023-269_a1b07822-805f-4c68-914f-1db1cead480a",
"productndc": "42023-269",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "216903",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)",
"product_no": "001",
"approval_date": "Feb 23, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE",
"proprietary_name": "PREVDUO",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "NDA216903",
"marketing_category": "NDA",
"nonproprietary_name": "neostigmine methylsulfate and glycopyrrolate",
"start_marketing_date": "20230515",
"active_numerator_strength": ".2; 1"
}Related drugs
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