Gabapentin Tablet
NDC Package 68382-607-05

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

Package Information

Gabapentin tablets is gabapentin is used with other medications to prevent and control seizures. This formulation utilizes a tablet delivery system. Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 68382-607 and is authorized under FDA application ANDA203934.

Identification & Billing

NDC Package Code
68382-607-05
Package Description
500 TABLET in 1 BOTTLE
Product Code
68382-607
11-Digit Billing Format
68382060705
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gabapentin
Non-Proprietary Name
Gabapentin
Substance Name
Gabapentin
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GABAPENTIN 600 mg/1
Pharmacologic Class
Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
Usage Information
Gabapentin is used with other medications to prevent and control seizures. It is also used to relieve nerve pain following shingles (a painful rash due to herpes zoster infection) in adults. Gabapentin is known as an anticonvulsant or antiepileptic drug.

Regulatory & Marketing

Labeler Name
Zydus Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA203934
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-25-2024
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68382-607). Click a package code to view its specific billing and regulatory data.

68382-607-16
90 TABLET in 1 BOTTLE
68382-607-77
10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK (68382-607-30)

* 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 68382-607-05 identifies a specific commercial package of 500 tablet in 1 bottle of Gabapentin, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. This tablet is formulated for oral use and contains gabapentin 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 Zydus Pharmaceuticals Usa Inc. on January 25, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Gabapentin is used with other medications to prevent and control seizures. It is also used to relieve nerve pain following shingles (a painful rash due to herpes zoster infection) in adults. Gabapentin is known as an anticonvulsant or antiepileptic drug.

How is this Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68382060705. 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)
68382-607-05
11-Digit CMS (5-4-2)
68382-0607-05

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