Gabapentin Tablet, Film Coated
NDC Package 71610-044-73

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, film coated delivery system. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 71610-044 and is authorized under FDA application ANDA203244.

Identification & Billing

NDC Package Code
71610-044-73
Package Description
135 TABLET, FILM COATED in 1 BOTTLE
Product Code
71610-044
11-Digit Billing Format
71610004473
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
135 EA
RxNorm Crosswalk
RxCUI: 310433 - gabapentin 600 MG Oral Tablet

Clinical Specifications

Proprietary Name
Gabapentin
Non-Proprietary Name
Gabapentin
Substance Name
Gabapentin
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GABAPENTIN 600 mg/1
Pharmacologic Class
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
Aphena Pharma Solutions - Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA203244
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-11-2014
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 (71610-044). Click a package code to view its specific billing and regulatory data.

71610-044-30
30 TABLET, FILM COATED in 1 BOTTLE
71610-044-45
45 TABLET, FILM COATED in 1 BOTTLE
71610-044-53
60 TABLET, FILM COATED in 1 BOTTLE
71610-044-60
90 TABLET, FILM COATED in 1 BOTTLE
71610-044-70
120 TABLET, FILM COATED in 1 BOTTLE
71610-044-80
180 TABLET, FILM COATED in 1 BOTTLE
71610-044-92
270 TABLET, FILM COATED in 1 BOTTLE

* 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 71610-044-73 identifies a specific commercial package of 135 tablet, film coated in 1 bottle of Gabapentin, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 135 billable units per package. This tablet, film coated 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 Aphena Pharma Solutions - Tennessee, Llc on January 11, 2014. 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 Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71610004473. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 135 total billable units per package. 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)
71610-044-73
11-Digit CMS (5-4-2)
71610-0044-73

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