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  5. NDC Package Code: 13925-535-01 Butalbital, Acetaminophen And Caffeine

NDC Package 13925-535-01 Butalbital, Acetaminophen And Caffeine

Capsule 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:
13925-535-01
Package Description:
100 CAPSULE in 1 BOTTLE
Product Code:
13925-535
Proprietary Name:
Butalbital, Acetaminophen And Caffeine
Non-Proprietary Name:
Butalbital, Acetaminophen And Caffeine
Substance Name:
Acetaminophen; Butalbital; Caffeine
Usage Information:
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.
11-Digit NDC Billing Format:
13925053501
NDC to RxNorm Crosswalk:
  • RxCUI: 238153 - butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Capsule
  • RxCUI: 238153 - acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule
  • RxCUI: 238153 - APAP 325 MG / butalbital 50 MG / Caffeine 40 MG Oral Capsule
  • 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Seton Pharmaceuticals Llc
    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
  • 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:
    ANDA214087
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-02-2022
    Listing Expiration Date:
    12-31-2025
    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 13925-535-01?

    The NDC Packaged Code 13925-535-01 is assigned to a package of 100 capsule in 1 bottle of Butalbital, Acetaminophen And Caffeine, a human prescription drug labeled by Seton Pharmaceuticals Llc. The product's dosage form is capsule and is administered via oral form.

    Is NDC 13925-535 included in the NDC Directory?

    Yes, Butalbital, Acetaminophen And Caffeine with product code 13925-535 is active and included in the NDC Directory. The product was first marketed by Seton Pharmaceuticals Llc on March 02, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 13925-535-01?

    The 11-digit format is 13925053501. 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
    5-3-213925-535-015-4-213925-0535-01