phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide

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

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

Drug Facts

Product Profile

Brand Name phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
Generic Name phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
Labeler ingenus pharmaceuticals, 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
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-666
Product ID 50742-666_5e9a2654-23e8-43de-a8fa-d981d7f13e40
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2021-08-01

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 50742666
Hyphenated Format 50742-666

Supplemental Identifiers

RxCUI
1046787
UPC
0350742665167 0350742665044 0350742666041
UNII
YQE403BP4D F2R8V82B84 451IFR0GXB 03J5ZE7KA5

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 phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide (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
  • 118 mL in 1 BOTTLE (50742-666-04)
  • 473 mL in 1 BOTTLE (50742-666-16)
source: ndc

Packages (2)

50742-666-04 118 mL in 1 BOTTLE (50742-666-04) 50742-666-16 473 mL in 1 BOTTLE (50742-666-16)

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)

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5e9a2654-23e8-43de-a8fa-d981d7f13e40", "openfda": {"upc": ["0350742665167", "0350742665044", "0350742666041"], "unii": ["YQE403BP4D", "F2R8V82B84", "451IFR0GXB", "03J5ZE7KA5"], "rxcui": ["1046787"], "spl_set_id": ["33bf2df5-bc53-4d57-a9e7-41f3fc0a03f0"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (50742-666-04)", "package_ndc": "50742-666-04", "marketing_start_date": "20210801"}, {"sample": false, "description": "473 mL in 1 BOTTLE (50742-666-16)", "package_ndc": "50742-666-16", "marketing_start_date": "20210801"}], "brand_name": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide", "product_id": "50742-666_5e9a2654-23e8-43de-a8fa-d981d7f13e40", "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": "50742-666", "dea_schedule": "CIV", "generic_name": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide", "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": "20210801", "listing_expiration_date": "20261231"}