Orbivan
NDC Package 59702-661-01

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

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

Orbivan is ™ Butalbital, Acetaminophen and Caffeine capsules 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. Marketed by Atley Pharmaceuticals, Inc., this product is identified by NDC 59702-661 and is authorized under FDA application ANDA040885.

Identification & Billing

NDC Package Code
59702-661-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
59702-661
11-Digit Billing Format
59702066101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 889520 - butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule
  • RxCUI: 889520 - acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule
  • RxCUI: 889520 - APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule
  • RxCUI: 977526 - acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [Orbivan]
  • RxCUI: 977526 - APAP 300 MG / butalbital 50 MG / Caffeine 40 MG Oral Capsule [Orbivan]

Clinical Specifications

Proprietary Name
Orbivan
Dosage Form
-
Usage Information
ORBIVAN™ Butalbital, Acetaminophen and Caffeine capsules 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.

Regulatory & Marketing

Labeler Name
Atley Pharmaceuticals, Inc.
FDA Application #
ANDA040885
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-23-2010
Listing Expiration
12-31-2017
Exclude Flag
I
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 (59702-661). Click a package code to view its specific billing and regulatory data.

59702-661-12
1 CAPSULE in 1 POUCH

* 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 59702-661-01 identifies a specific commercial package of 100 capsule in 1 bottle of Orbivan, labeled by Atley Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 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 Atley Pharmaceuticals, Inc. on April 23, 2010. The current certification is valid through December 31, 2017.

How is this Atley Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59702066101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
59702-661-01
11-Digit CMS (5-4-2)
59702-0661-01

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