NDC Package 71335-0653-3 Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate

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

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:
71335-0653-3
Package Description:
30 CAPSULE in 1 BOTTLE
Product Code:
Proprietary Name:
Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate
Non-Proprietary Name:
Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate
Substance Name:
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate
Usage Information:
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]:Have not been tolerated, or are not expected to be tolerated,Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
11-Digit NDC Billing Format:
71335065303
NDC to RxNorm Crosswalk:
  • RxCUI: 993943 - butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule
  • RxCUI: 993943 - acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule
  • RxCUI: 993943 - APAP 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bryant Ranch Prepack
    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.
  • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA075929
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-22-2002
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N

    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
    71335-0653-120 CAPSULE in 1 BOTTLE
    71335-0653-290 CAPSULE in 1 BOTTLE
    71335-0653-460 CAPSULE in 1 BOTTLE
    71335-0653-5100 CAPSULE in 1 BOTTLE
    71335-0653-615 CAPSULE in 1 BOTTLE
    71335-0653-718 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71335-0653-3?

    The NDC Packaged Code 71335-0653-3 is assigned to a package of 30 capsule in 1 bottle of Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is capsule and is administered via oral form.

    Is NDC 71335-0653 included in the NDC Directory?

    Yes, Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate with product code 71335-0653 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on April 22, 2002 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 71335-0653-3?

    The 11-digit format is 71335065303. 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
    5-4-171335-0653-35-4-271335-0653-03