Ko-lanta Suspension
NDC Package 57896-004-12
Package Information
Ko-lanta (aluminum hydroxide, magnesium hydroxide, dimethicone) suspension is shake well before useadults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctordo not take more than 24 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weekschildren under 12 years: ask a doctor. This formulation utilizes a suspension delivery system. Marketed by Geri-care Pharmaceuticals, Corp, this product is identified by NDC 57896-004 and is authorized under FDA application M001.
Identification & Billing
- RxCUI: 307746 - aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral Suspension
- RxCUI: 307746 - aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral Suspension
- RxCUI: 307746 - aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral Suspension
- RxCUI: 307746 - aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral Suspension
- RxCUI: 307746 - aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral Suspension
Clinical Specifications
- Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
- Increased Large Intestinal Motility - [PE] (Physiologic Effect)
- Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
- Osmotic Activity - [MoA] (Mechanism of Action)
- Osmotic Laxative - [EPC] (Established Pharmacologic Class)
- Skin Barrier Activity - [PE] (Physiologic Effect)
- Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
Regulatory & Marketing
Hierarchy Structure
- 57896 - Geri-care Pharmaceuticals, Corp
- 57896-004 - Ko-lanta
- 57896-004-12 - 355 mL in 1 BOTTLE
- 57896-004 - Ko-lanta
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 57896-004-12 identifies a specific commercial package of 355 ml in 1 bottle of Ko-lanta, a human over the counter drug labeled by Geri-care Pharmaceuticals, Corp. This suspension is formulated for oral use and contains aluminum hydroxide; dimethicone; magnesium hydroxide 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 Geri-care Pharmaceuticals, Corp on January 01, 2020. The current certification is valid through December 31, 2026.
How is this Geri-care Pharmaceuticals, Corp product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 57896000412. 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.
