Gabapentin
NDC Package 43353-710-60
Package Information
Gabapentin is used with other medications to prevent and control seizures. Marketed by Aphena Pharma Solutions - Tennessee, Inc., this product is identified by NDC 43353-710 and is authorized under FDA application ANDA090705.
Identification & Billing
- RxCUI: 310430 - gabapentin 100 MG Oral Capsule
- RxCUI: 310431 - gabapentin 300 MG Oral Capsule
- RxCUI: 310432 - gabapentin 400 MG Oral Capsule
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 43353 - Aphena Pharma Solutions - Tennessee, Inc.
- 43353-710 - Gabapentin
- 43353-710-60 - 90 CAPSULE in 1 BOTTLE, PLASTIC
- 43353-710 - Gabapentin
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 (43353-710). 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 43353-710-60 identifies a specific commercial package of 90 capsule in 1 bottle, plastic of Gabapentin, labeled by Aphena Pharma Solutions - Tennessee, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package. 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 Aphena Pharma Solutions - Tennessee, Inc. on May 17, 2010. The current certification is valid through December 31, 2017.
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, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 43353071060. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.