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  5. NDC Package Code: 70010-054-05 Butalbital And Acetaminophen

NDC Package 70010-054-05 Butalbital And Acetaminophen

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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:
70010-054-05
Package Description:
500 CAPSULE in 1 BOTTLE
Product Code:
70010-054
Proprietary Name:
Butalbital And Acetaminophen
Non-Proprietary Name:
Butalbital And Acetaminophen
Substance Name:
Acetaminophen; Butalbital
Usage Information:
Butalbital and acetaminophen 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.
11-Digit NDC Billing Format:
70010005405
NDC to RxNorm Crosswalk:
  • RxCUI: 1995136 - butalbital 50 MG / acetaminophen 300 MG Oral Capsule
  • RxCUI: 1995136 - acetaminophen 300 MG / butalbital 50 MG Oral Capsule
  • RxCUI: 1995136 - APAP 300 MG / butalbital 50 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Granules Pharmaceuticals Inc.
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 300 mg/1
  • BUTALBITAL 50 mg/1
    • Pharmacologic Class(es):
  • Barbiturate - [EPC] (Established Pharmacologic Class)
  • Barbiturates - [CS]
    • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA213115
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-20-2020
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 CodePackage Description
    70010-054-01100 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70010-054-05?

    The NDC Packaged Code 70010-054-05 is assigned to a package of 500 capsule in 1 bottle of Butalbital And Acetaminophen, a human prescription drug labeled by Granules Pharmaceuticals Inc.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 70010-054 included in the NDC Directory?

    Yes, Butalbital And Acetaminophen with product code 70010-054 is active and included in the NDC Directory. The product was first marketed by Granules Pharmaceuticals Inc. on January 20, 2020 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 70010-054-05?

    The 11-digit format is 70010005405. 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 5-3-2 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-270010-054-055-4-270010-0054-05