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  5. NDC Package Code: 50268-553-13 Butalbital, Acetaminophen, Caffeine

NDC Package 50268-553-13 Butalbital, Acetaminophen, Caffeine

Butalbital,Acetaminophen,And Caffeine 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:
50268-553-13
Package Description:
30 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK (50268-553-11)
Product Code:
50268-553
Proprietary Name:
Butalbital, Acetaminophen, Caffeine
Non-Proprietary Name:
Butalbital, Acetaminophen, And Caffeine
Substance Name:
Acetaminophen; Butalbital; 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:
50268055313
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Avpak
    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 325 mg/1
  • BUTALBITAL 50 mg/1
  • CAFFEINE 40 mg/1
    • Pharmacologic Class(es):
  • Barbiturate - [EPC] (Established Pharmacologic Class)
  • Barbiturates - [CS]
  • Central Nervous System Stimulant - [EPC] (Established Pharmacologic Class)
  • Central Nervous System Stimulation - [PE] (Physiologic Effect)
  • Methylxanthine - [EPC] (Established Pharmacologic Class)
  • Xanthines - [CS]
    • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA209587
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-11-2022
    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 50268-553-13?

    The NDC Packaged Code 50268-553-13 is assigned to a package of 30 blister pack in 1 box / 1 tablet in 1 blister pack (50268-553-11) of Butalbital, Acetaminophen, Caffeine, a human prescription drug labeled by Avpak. The product's dosage form is tablet and is administered via oral form.

    Is NDC 50268-553 included in the NDC Directory?

    Yes, Butalbital, Acetaminophen, Caffeine with product code 50268-553 is active and included in the NDC Directory. The product was first marketed by Avpak on August 11, 2022 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 NDC billing unit for package 50268-553-13?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 50268-553-13?

    The 11-digit format is 50268055313. 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
    5-3-250268-553-135-4-250268-0553-13