Pantoprazole Sodium Granule, Delayed Release
NDC Package 42799-952-30
Package Information
Pantoprazole Sodium granules is pantoprazole is used to treat certain stomach and esophagus problems (such as acid reflux). This formulation utilizes a granule, delayed release delivery system. Marketed by Edenbridge Pharmaceuticals Llc., this product is identified by NDC 42799-952 and is authorized under FDA application ANDA216247.
Identification & Billing
- RxCUI: 763306 - pantoprazole sodium 40 MG Delayed Release Oral Granules
- RxCUI: 763306 - pantoprazole 40 MG Oral Granules
- RxCUI: 763306 - pantoprazole 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral Granules
- RxCUI: 763306 - pantoprazole 40 MG Enteric Coated Oral Granules for Oral Suspension
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 42799 - Edenbridge Pharmaceuticals Llc.
- 42799-952 - Pantoprazole Sodium
- 42799-952-30 - 30 PACKET in 1 CARTON / 1 GRANULE, DELAYED RELEASE in 1 PACKET (42799-952-01)
- 42799-952 - Pantoprazole Sodium
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 42799-952-30 identifies a specific commercial package of 30 packet in 1 carton / 1 granule, delayed release in 1 packet (42799-952-01) of Pantoprazole Sodium, a human prescription drug labeled by Edenbridge Pharmaceuticals Llc.. This granule, delayed release is formulated for oral use and contains pantoprazole sodium 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 Edenbridge Pharmaceuticals Llc. on June 16, 2023. The current certification is valid through December 31, 2027.
What are the primary indications for this medication?
Pantoprazole is used to treat certain stomach and esophagus problems (such as acid reflux). It works by decreasing the amount of acid your stomach makes. This medication relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. It helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Pantoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).
How is this Edenbridge Pharmaceuticals Llc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 42799095230. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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.