Seromycin
NDC Package 13845-1203-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Seromycin is iNDICATIONS AND USAGESeromycin® is indicated in the treatment of active pulmonary and extrapulmonary tuberculosis (including renal disease) when the causative organisms are susceptible to this drug and when treatment with the primary medications (streptomycin, isoniazid, rifampin, and ethambutol) has proved inadequate. Marketed by Parsolex Gmp Center, Inc., this product is identified by NDC 13845-1203 and is authorized under FDA application ANDA060593.

Identification & Billing

NDC Package Code
13845-1203-2
Package Description
3 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK
Product Code
13845-1203
11-Digit Billing Format
13845120302
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Seromycin
Dosage Form
-
Usage Information
INDICATIONS AND USAGESeromycin® is indicated in the treatment of active pulmonary and extrapulmonary tuberculosis (including renal disease) when the causative organisms are susceptible to this drug and when treatment with the primary medications (streptomycin, isoniazid, rifampin, and ethambutol) has proved inadequate. Like all antituberculosis drugs, Seromycin® should be administered in conjunction with other effective chemotherapy and not as the sole therapeutic agent.Seromycin® may be effective in the treatment of acute urinary tract infections caused by susceptible strains of gram- positive and gram-negative bacteria. Use of Seromycin® in these infections should be considered only when more conventional therapy has failed and when the organism has been demonstrated to be susceptible to the drug.

Regulatory & Marketing

Labeler Name
Parsolex Gmp Center, Inc.
FDA Application #
ANDA060593
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-01-2009
Listing Expiration
12-31-2024
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 13845-1203-2 identifies a specific commercial package of 3 blister pack in 1 carton / 10 capsule in 1 blister pack of Seromycin, labeled by Parsolex Gmp Center, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Parsolex Gmp Center, Inc. on March 01, 2009. The current certification is valid through December 31, 2024.

How is this Parsolex Gmp Center, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13845120302. 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:

10-Digit Format (5-4-1)
13845-1203-2
11-Digit CMS (5-4-2)
13845-1203-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.