donnatal

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

Labeler: advanz pharma (us) corp.
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 advanz pharma (us) corp.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

atropine sulfate .0194 mg/1, hyoscyamine sulfate .1037 mg/1, phenobarbital 16.2 mg/1, scopolamine hydrobromide .0065 mg/1

Manufacturer
Advanz Pharma (US) Corp.

Identifiers & Regulatory

Product NDC 59212-425
Product ID 59212-425_0395fab5-b3e6-4822-872c-16002ae8ff58
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 1980-12-30

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 59212425
Hyphenated Format 59212-425

Supplemental Identifiers

RxCUI
1046815 1046978
UPC
0359212425102
UNII
03J5ZE7KA5 F2R8V82B84 YQE403BP4D 451IFR0GXB

Packaging Origin

Original Packager
true

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/1
  • .1037 mg/1
  • 16.2 mg/1
  • .0065 mg/1
source: ndc
Packaging
  • 4 TABLET in 1 BOTTLE, PLASTIC (59212-425-04)
  • 100 TABLET in 1 BOTTLE, PLASTIC (59212-425-10)
source: ndc

Packages (2)

59212-425-04 4 TABLET in 1 BOTTLE, PLASTIC (59212-425-04) 59212-425-10 100 TABLET in 1 BOTTLE, PLASTIC (59212-425-10)

Ingredients (4)

atropine sulfate (.0194 mg/1) hyoscyamine sulfate (.1037 mg/1) phenobarbital (16.2 mg/1) scopolamine hydrobromide (.0065 mg/1)

Linked Drug Pages (1)

Donnatal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0395fab5-b3e6-4822-872c-16002ae8ff58", "openfda": {"upc": ["0359212425102"], "unii": ["03J5ZE7KA5", "F2R8V82B84", "YQE403BP4D", "451IFR0GXB"], "rxcui": ["1046815", "1046978"], "spl_set_id": ["c93cccdc-2f92-4cb3-9d14-06acdd51d94c"], "manufacturer_name": ["Advanz Pharma (US) Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET in 1 BOTTLE, PLASTIC (59212-425-04)", "package_ndc": "59212-425-04", "marketing_start_date": "19801230"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (59212-425-10)", "package_ndc": "59212-425-10", "marketing_start_date": "19801230"}], "brand_name": "Donnatal", "product_id": "59212-425_0395fab5-b3e6-4822-872c-16002ae8ff58", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "59212-425", "dea_schedule": "CIV", "generic_name": "PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE", "labeler_name": "Advanz Pharma (US) Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donnatal", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": ".0194 mg/1"}, {"name": "HYOSCYAMINE SULFATE", "strength": ".1037 mg/1"}, {"name": "PHENOBARBITAL", "strength": "16.2 mg/1"}, {"name": "SCOPOLAMINE HYDROBROMIDE", "strength": ".0065 mg/1"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "19801230", "listing_expiration_date": "20261231"}