Fexofenadine Hydrochloride Tablet
NDC Package 55111-784-35
Package Information
Fexofenadine Hydrochloride tablets is 30 mgadults and children 12 years of age and over take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hourschildren 6 to under 12 years of agetake one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hourschildren under 6 years of agedo not useAdults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctor60 mgadults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hourschildren under 12 years of agedo not useAdults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctor180 mgadults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hourschildren under 12 years of agedo not useAdults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctor. This formulation utilizes a tablet delivery system. Marketed by Dr. Reddy's Laboratories Limited, this product is identified by NDC 55111-784 and is authorized under FDA application ANDA076502.
Identification & Billing
- RxCUI: 997420 - fexofenadine HCl 180 MG 24 HR Oral Tablet
- RxCUI: 997420 - fexofenadine hydrochloride 180 MG Oral Tablet
- RxCUI: 997488 - fexofenadine HCl 30 MG Oral Tablet
- RxCUI: 997488 - fexofenadine hydrochloride 30 MG Oral Tablet
- RxCUI: 997501 - fexofenadine HCl 60 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 55111 - Dr. Reddy's Laboratories Limited
- 55111-784 - Fexofenadine Hydrochloride
- 55111-784-35 - 2 BLISTER PACK in 1 CARTON / 5 TABLET in 1 BLISTER PACK
- 55111-784 - Fexofenadine Hydrochloride
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.
* Please review the full disclaimer at the bottom of this page.
Other Available Packages
The following commercial packages are registered under the same Product NDC (55111-784). Click a package code to view its specific billing and regulatory data.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 55111-784-35 identifies a specific commercial package of 2 blister pack in 1 carton / 5 tablet in 1 blister pack of Fexofenadine Hydrochloride, a human over the counter drug labeled by Dr. Reddy's Laboratories Limited. This tablet is formulated for oral use and contains fexofenadine hydrochloride 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 Dr. Reddy's Laboratories Limited on January 03, 2011. The current certification is valid through December 31, 2026.
How is this Dr. Reddy's Laboratories Limited product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 55111078435. 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.
