Macrobid
NDC Package 69776-101-01

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 discontinued by the firm.

Macrobid is a medication an antibiotic used to treat bladder infections (acute cystitis). Marketed by Sunny Pharmtech Inc., this product is identified by NDC 69776-101 and is authorized under FDA application ANDA208516.

Identification & Billing

NDC Package Code
69776-101-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
69776-101
11-Digit Billing Format
69776010101

Clinical Specifications

Proprietary Name
Macrobid
Dosage Form
-
Usage Information
This medication is an antibiotic used to treat bladder infections (acute cystitis). It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. This medication should not be used in infants younger than 1 month old (see also Precautions section). This drug should not be used to treat infections outside the bladder (including kidney infections such as pyelonephritis or perinephric abscesses).

Regulatory & Marketing

Labeler Name
Sunny Pharmtech Inc.
FDA Application #
ANDA208516
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2018
End Marketing Date
06-01-2018
Listing Expiration
06-01-2018
Exclude Flag
D
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 69776-101-01 identifies a specific commercial package of 100 capsule in 1 bottle of Macrobid, labeled by Sunny Pharmtech 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 Sunny Pharmtech Inc. on January 01, 2018. The current certification is valid through June 01, 2018.

What are the primary indications for this medication?

This medication is an antibiotic used to treat bladder infections (acute cystitis). It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. This medication should not be used in infants younger than 1 month old (see also Precautions section). This drug should not be used to treat infections outside the bladder (including kidney infections such as pyelonephritis or perinephric abscesses).

How is this Sunny Pharmtech Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69776010101. 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 (5-3-2)
69776-101-01
11-Digit CMS (5-4-2)
69776-0101-01

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