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  5. NDC Package Code: 70518-2995-0 Butalbital, Acetaminophen, Caffeine

NDC Package 70518-2995-0 Butalbital, Acetaminophen, Caffeine

Butalbital,Acetaminophen,And Caffeine Tablet, Coated 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:
70518-2995-0
Package Description:
30 TABLET, COATED in 1 BLISTER PACK
Product Code:
70518-2995
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:
70518299500
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:
    Remedyrepack Inc.
    Dosage Form:
    Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
    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:
    01-19-2021
    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
    70518-2995-160 TABLET, COATED in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70518-2995-0?

    The NDC Packaged Code 70518-2995-0 is assigned to a package of 30 tablet, coated in 1 blister pack of Butalbital, Acetaminophen, Caffeine, a human prescription drug labeled by Remedyrepack Inc.. The product's dosage form is tablet, coated and is administered via oral form.

    Is NDC 70518-2995 included in the NDC Directory?

    Yes, Butalbital, Acetaminophen, Caffeine with product code 70518-2995 is active and included in the NDC Directory. The product was first marketed by Remedyrepack Inc. on January 19, 2021 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 70518-2995-0?

    The 11-digit format is 70518299500. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-170518-2995-05-4-270518-2995-00