NDC Package 68071-2365-6 Butalbital, Acetaminophen, Caffeine

View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:

68071-2365-6

Package Description:

60 TABLET, COATED in 1 BOTTLE

Product Code:

68071-2365

Proprietary Name:

Butalbital, Acetaminophen, Caffeine

Usage Information:

Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

11-Digit NDC Billing Format:

68071236506

NDC to RxNorm Crosswalk:

RxCUI: 238154 - butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet
RxCUI: 238154 - acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet
RxCUI: 238154 - APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet

Labeler Name:

Nucare Pharmaceuticals,inc.

Sample Package:

FDA Application Number:

ANDA209587

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

03-05-2019

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

68071 - Nucare Pharmaceuticals,inc.
- 68071-2365 - Butalbital, Acetaminophen, Caffeine
  - 68071-2365-6 - 60 TABLET, COATED in 1 BOTTLE

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
68071-2365-3	30 TABLET, COATED in 1 BOTTLE
68071-2365-8	180 TABLET, COATED in 1 BOTTLE
68071-2365-9	90 TABLET, COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 68071-2365-6?

The NDC Packaged Code 68071-2365-6 is assigned to a package of 60 tablet, coated in 1 bottle of Butalbital, Acetaminophen, Caffeine, labeled by Nucare Pharmaceuticals,inc.. The product's dosage form is and is administered via form.

Is NDC 68071-2365 included in the NDC Directory?

No, Butalbital, Acetaminophen, Caffeine with product code 68071-2365 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Nucare Pharmaceuticals,inc. on March 05, 2019 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 68071-2365-6?

The 11-digit format is 68071236506. 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	68071-2365-6	5-4-2	68071-2365-06

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