Home NDC 50742-666-04 Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Product NDC 50742-666
Requested package NDC 50742-666-04
11-digit product format 507420666
Labeler code 50742
Product ID 50742-666_5e9a2654-23e8-43de-a8fa-d981d7f13e40
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Dosage form ELIXIR
Route ORAL
Labeler Ingenus Pharmaceuticals, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2021-08-01
Substance ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE
Active strength .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENOBARBITAL .0194 mg/5mL HYOSCYAMINE SULFATE .1037 mg/5mL ATROPINE SULFATE 16.2 mg/5mL SCOPOLAMINE HYDROBROMIDE .0065 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1046787 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50742-666-04 Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide 118 mL in 1 BOTTLE ELIXIR 118 2 50742-666-16 Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide 473 mL in 1 BOTTLE ELIXIR 473 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50742-666 PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE ELIXIR [INGENUS PHARMACEUTICALS, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20230120_33bf2df5-bc53-4d57-a9e7-41f3fc0a03f0.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE Ingenus Pharmaceuticals, LLC 33bf2df5-bc53-4d57-a9e7-41f3fc0a03f0 2023-01-12 Warnings, Adverse reactions Exact identifier ndc (package): 50742-666-04 ndc (product): 50742-666 ndc11 (package): 50742066604
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50742-666-04 50742066604 118 mL in 1 BOTTLE (50742-666-04) 118 ml 2021-08-01 0000-00-00 No No Current