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United States · US · US:59212-422_f15ad820-c07e-4e6b-a154-7ddca20bc838

Donnatal

In shortageUNIISPLATC A03BA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAdvanz Pharma (US) Corp.
CountryUS (United States)
ATC codeA03BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5921242204
    118 mL in 1 BOTTLE (59212-422-04)
  • ndc11
    5921242210
    10 mL in 1 BOTTLE (59212-422-10)
  • ndc11
    5921242216
    473 mL in 1 BOTTLE (59212-422-16)

Annotations

UNII (FDA Substance ID)
03J5ZE7KA5
ATROPINE SULFATE
RxCUI 153971
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Atropine Sulfate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "03J5ZE7KA5",
    "rxcui": "153971",
    "inchikey": "JPKKQJKQTPNWTR-WFEZVHBLSA-N;JPKKQJKQTPNWTR-AAWIVWGASA-N",
    "display_name": "ATROPINE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c93cccdc-2f92-4cb3-9d14-06acdd51d94c": {
      "match": "brand_token",
      "title": "DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [ADVANZ PHARMA (US) CORP.]",
      "spl_version": "14",
      "published_date": "2024-12-24"
    }
  },
  "productid": "59212-422_f15ad820-c07e-4e6b-a154-7ddca20bc838",
  "productndc": "59212-422",
  "dosage_form": "ELIXIR",
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE",
  "shortage_reason": "Atropine Sulfate Injection",
  "shortage_status": "current",
  "proprietary_name": "Donnatal",
  "active_ingred_unit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
  "application_number": null,
  "marketing_category": "UNAPPROVED DRUG OTHER",
  "nonproprietary_name": "phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide",
  "start_marketing_date": "19801230",
  "active_numerator_strength": ".0194; .1037; 16.2; .0065"
}

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