donnatal

Generic: phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide

Labeler: vistapharm, llc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name donnatal
Generic Name phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
Labeler vistapharm, llc
Dosage Form ELIXIR
Routes
ORAL
Active Ingredients

atropine sulfate .0194 mg/5mL, hyoscyamine sulfate .1037 mg/5mL, phenobarbital 16.2 mg/5mL, scopolamine hydrobromide .0065 mg/5mL

Manufacturer
VistaPharm, LLC

Identifiers & Regulatory

Product NDC 66689-063
Product ID 66689-063_b528eb39-f078-452f-939c-2daebd4d70ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2017-10-26

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa] cholinergic muscarinic antagonist [epc] cholinergic muscarinic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66689063
Hyphenated Format 66689-063

Supplemental Identifiers

RxCUI
1046787 1046924
UNII
03J5ZE7KA5 F2R8V82B84 YQE403BP4D 451IFR0GXB

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name donnatal (source: ndc)
Generic Name phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .0194 mg/5mL
  • .1037 mg/5mL
  • 16.2 mg/5mL
  • .0065 mg/5mL
source: ndc
Packaging
  • 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)
  • 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)
  • 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)
  • 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)
source: ndc

Packages (4)

66689-063-10 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) 66689-063-40 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) 66689-063-50 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) 66689-063-99 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)

Ingredients (4)

atropine sulfate (.0194 mg/5mL) hyoscyamine sulfate (.1037 mg/5mL) phenobarbital (16.2 mg/5mL) scopolamine hydrobromide (.0065 mg/5mL)

Linked Drug Pages (1)

Donnatal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b528eb39-f078-452f-939c-2daebd4d70ff", "openfda": {"unii": ["03J5ZE7KA5", "F2R8V82B84", "YQE403BP4D", "451IFR0GXB"], "rxcui": ["1046787", "1046924"], "spl_set_id": ["11a48ba9-576b-4e8c-9536-6e83636d6930"], "manufacturer_name": ["VistaPharm, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "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)", "package_ndc": "66689-063-10", "marketing_start_date": "20171026"}, {"sample": false, "description": "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)", "package_ndc": "66689-063-40", "marketing_start_date": "20171026"}, {"sample": false, "description": "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)", "package_ndc": "66689-063-50", "marketing_start_date": "20171026"}, {"sample": false, "description": "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)", "package_ndc": "66689-063-99", "marketing_start_date": "20171026"}], "brand_name": "Donnatal", "product_id": "66689-063_b528eb39-f078-452f-939c-2daebd4d70ff", "dosage_form": "ELIXIR", "pharm_class": ["Anticholinergic [EPC]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "66689-063", "dea_schedule": "CIV", "generic_name": "phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide", "labeler_name": "VistaPharm, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donnatal", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": ".0194 mg/5mL"}, {"name": "HYOSCYAMINE SULFATE", "strength": ".1037 mg/5mL"}, {"name": "PHENOBARBITAL", "strength": "16.2 mg/5mL"}, {"name": "SCOPOLAMINE HYDROBROMIDE", "strength": ".0065 mg/5mL"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20171026", "listing_expiration_date": "20261231"}