Home NDC 50742-667-01 Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide
Product NDC 50742-667
Requested package NDC 50742-667-01
11-digit product format 507420667
Labeler code 50742
Product ID 50742-667_3796f3d7-7e45-4a49-aaa2-7363c197b2f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide
Dosage form TABLET
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/1; mg/1; mg/1; mg/1
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 and Scopolamine Hydrobromide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENOBARBITAL .0194 mg/1 HYOSCYAMINE SULFATE .1037 mg/1 ATROPINE SULFATE 16.2 mg/1 SCOPOLAMINE HYDROBROMIDE .0065 mg/1
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 1046815 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 50742-667-01 Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide 100 in 1 BOTTLE, PLASTIC TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50742-667 PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE AND SCOPOLAMINE HYDROBROMIDE TABLET [INGENUS PHARMACEUTICALS, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20230120_0dd71f55-e009-48dd-809d-5f651f7521de.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.
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 50742-667-01 50742066701 100 TABLET in 1 BOTTLE, PLASTIC (50742-667-01) 100 tablet 2021-08-01 0000-00-00 No No Current