Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate And Scopolamine Hydrobromide Tablet
NDC Package 50742-667-01
Package Information
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate And Scopolamine Hydrobromide tablets is glaucoma;obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy);obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.);paralytic ileus, intestinal atony of the elderly or debilitated patient;unstable cardiovascular status in acute hemorrhage;severe ulcerative colitis especially if complicated by toxic megacolon;myasthenia gravis;hiatal hernia associated with reflux esophagitis;in patients with known hypersensitivity to any of the ingredients.Phenobarbital is contraindicated in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement. This formulation utilizes a tablet delivery system. Marketed by Ingenus Pharmaceuticals, Llc, this product is identified by NDC 50742-667.
Identification & Billing
- RxCUI: 1046815 - atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / PHENobarbital 16.2 MG / scopolamine HBr 0.0065 MG Oral Tablet
- RxCUI: 1046815 - atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral Tablet
Clinical Specifications
- Anticholinergic - [EPC] (Established Pharmacologic Class)
- Anticholinergic - [EPC] (Established Pharmacologic Class)
- Cholinergic Antagonists - [MoA] (Mechanism of Action)
- Cholinergic Muscarinic Antagonist - [EPC] (Established Pharmacologic Class)
- Cholinergic Muscarinic Antagonists - [MoA] (Mechanism of Action)
Regulatory & Marketing
Hierarchy Structure
- 50742 - Ingenus Pharmaceuticals, Llc
- 50742-667 - Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate And Scopolamine Hydrobromide
- 50742-667-01 - 100 TABLET in 1 BOTTLE, PLASTIC
- 50742-667 - Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate And Scopolamine Hydrobromide
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 50742-667-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate And Scopolamine Hydrobromide, a human prescription drug labeled by Ingenus Pharmaceuticals, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet is formulated for oral use and contains atropine sulfate; hyoscyamine sulfate; phenobarbital; scopolamine hydrobromide as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Ingenus Pharmaceuticals, Llc on August 01, 2021. The current certification is valid through December 31, 2026.
How is this Ingenus Pharmaceuticals, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 50742066701. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.