NDC Package 61294-9991-6 Pregabalin

Powder - View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

61294-9991-6

Package Description:

2 kg in 1 DRUM

Product Code:

61294-9991

Non-Proprietary Name:

Pregabalin

Substance Name:

Pregabalin

Usage Information:

This medication is used to treat pain caused by nerve damage due to diabetes, shingles (herpes zoster) infection, or spinal cord injury. This medication is also used to treat pain in people with fibromyalgia. It is also used with other medications to treat certain types of seizures (focal seizures).

11-Digit NDC Billing Format:

61294999106

Product Type:

Bulk Ingredient

Labeler Name:

Kopran Research Laboratories Limited

Dosage Form:

Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

Active Ingredient(s):

PREGABALIN 1 kg/kg

DEA Schedule:

Schedule V (CV) Substances

Sample Package:

N/A

Marketing Category:

BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.

Start Marketing Date:

05-15-2023

Listing Expiration Date:

12-31-2024

Exclude Flag:

Unfinished Product:

Yes

Code Structure:

61294 - Kopran Research Laboratories Limited
- 61294-9991 -
  - 61294-9991-6 - 2 kg in 1 DRUM

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
61294-9991-3	25 kg in 1 DRUM
61294-9991-4	10 kg in 1 DRUM
61294-9991-5	5 kg in 1 DRUM
61294-9991-7	1 kg in 1 DRUM
61294-9991-8	.5 kg in 1 DRUM
61294-9991-9	.1 kg in 1 DRUM

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 61294-9991-6?

The NDC Packaged Code 61294-9991-6 is assigned to an UNFINISHED drug package of 2 kg in 1 drum of Pregabalin, a bulk ingredient labeled by Kopran Research Laboratories Limited. The product's dosage form is powder and is administered via form.

Is NDC 61294-9991 included in the NDC Directory?

Yes, Pregabalin is an UNFINISHED PRODUCT with code 61294-9991 that is active and included in the NDC Directory. The product was first marketed by Kopran Research Laboratories Limited on May 15, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 61294-9991-6?

The 11-digit format is 61294999106. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	61294-9991-6	5-4-2	61294-9991-06

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