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  5. NDC Package Code: 81005-123-01 Butalbital And Acetaminophen

NDC Package 81005-123-01 Butalbital And Acetaminophen

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

Table of Contents

    1. Package Information
    2. 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:
81005-123-01
Package Description:
100 TABLET in 1 BOTTLE
Product Code:
81005-123
Proprietary Name:
Butalbital And Acetaminophen
Non-Proprietary Name:
Butalbital And Acetaminophen
Substance Name:
Acetaminophen; Butalbital
Usage Information:
Butalbital and Acetaminophen 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:
81005012301
NDC to RxNorm Crosswalk:
  • RxCUI: 1249617 - butalbital 50 MG / acetaminophen 300 MG Oral Tablet
  • RxCUI: 1249617 - acetaminophen 300 MG / butalbital 50 MG Oral Tablet
  • RxCUI: 1249617 - APAP 300 MG / butalbital 50 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aarkish Pharmaceuticals Nj Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    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:
    ANDA214955
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-21-2023
    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.

    Frequently Asked Questions

    What is NDC 81005-123-01?

    The NDC Packaged Code 81005-123-01 is assigned to a package of 100 tablet in 1 bottle of Butalbital And Acetaminophen, a human prescription drug labeled by Aarkish Pharmaceuticals Nj Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 81005-123 included in the NDC Directory?

    Yes, Butalbital And Acetaminophen with product code 81005-123 is active and included in the NDC Directory. The product was first marketed by Aarkish Pharmaceuticals Nj Inc. on August 21, 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 81005-123-01?

    The 11-digit format is 81005012301. 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
    5-3-281005-123-015-4-281005-0123-01