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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

  • ndc11
    4202326905
    5 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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