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United States · US · US:66689-063_b528eb39-f078-452f-939c-2daebd4d70ff

Donnatal

In shortageUNIISPLATC A03BA

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

Identification

ManufacturerVistaPharm, LLC
CountryUS (United States)
ATC codeA03BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6668906310
    1 TRAY in 1 CASE (66689-063-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-063-01)
  • ndc11
    6668906340
    4 TRAY in 1 CASE (66689-063-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-063-01)
  • ndc11
    6668906350
    5 TRAY in 1 CASE (66689-063-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-063-01)
  • ndc11
    6668906399
    10 TRAY in 1 CASE (66689-063-99) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-063-01)

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": "66689-063_b528eb39-f078-452f-939c-2daebd4d70ff",
  "productndc": "66689-063",
  "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": "20171026",
  "active_numerator_strength": ".0194; .1037; 16.2; .0065"
}

Related drugs

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