NDC 71335-0653 Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate
Capsule Oral

Product Information

What is NDC 71335-0653?

The NDC code 71335-0653 is assigned by the FDA to the product Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate which is a human prescription drug product labeled by Bryant Ranch Prepack. The product's dosage form is capsule and is administered via oral form. The product is distributed in 7 packages with assigned NDC codes 71335-0653-1 20 capsule in 1 bottle , 71335-0653-2 90 capsule in 1 bottle , 71335-0653-3 30 capsule in 1 bottle , 71335-0653-4 60 capsule in 1 bottle , 71335-0653-5 100 capsule in 1 bottle , 71335-0653-6 15 capsule in 1 bottle , 71335-0653-7 18 capsule in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code71335-0653
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormCapsule - 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) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Bryant Ranch Prepack
Labeler Code71335
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
ANDA075929
DEA Schedule What is the Drug Enforcement Administration (DEA) CIII Schedule?
The controlled substances in the CIII schedule have an abuse potential and dependence liability less than those in schedules CI and CII, and have an accepted medical use in the United States. Schedule CIII controlled substances include preparations containing limited quantities of certain narcotic drugs, and other nonnarcotic drugs such as: derivatives of barbituric acid, except those that are listed in another schedule, glutethimide (Doriden), methyprylon (Noludar), nalorphine, benzphetamine, chlorphentermine, clortermine, and phendimetrazine.
Schedule III (CIII) Substances
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-22-2002
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate?


Product Characteristics

Color(s)BLUE (C48333 - LIGHT BLUE OPAQUE)
GRAY (C48324 - GREY OPAQUE)
ShapeCAPSULE (C48336)
Size(s)22 MM
Imprint(s)V;3109
Score1

Product Packages

NDC Code 71335-0653-1

Package Description: 20 CAPSULE in 1 BOTTLE

NDC Code 71335-0653-2

Package Description: 90 CAPSULE in 1 BOTTLE

NDC Code 71335-0653-3

Package Description: 30 CAPSULE in 1 BOTTLE

NDC Code 71335-0653-4

Package Description: 60 CAPSULE in 1 BOTTLE

NDC Code 71335-0653-5

Package Description: 100 CAPSULE in 1 BOTTLE

NDC Code 71335-0653-6

Package Description: 15 CAPSULE in 1 BOTTLE

NDC Code 71335-0653-7

Package Description: 18 CAPSULE in 1 BOTTLE

Product Details

What are Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ACETAMINOPHEN 325 mg/1 - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
  • BUTALBITAL 50 mg/1
  • CAFFEINE 40 mg/1 - A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Caffeine's most notable pharmacological effect is as a central nervous system stimulant, increasing alertness and producing agitation. It also relaxes SMOOTH MUSCLE, stimulates CARDIAC MUSCLE, stimulates DIURESIS, and appears to be useful in the treatment of some types of headache. Several cellular actions of caffeine have been observed, but it is not entirely clear how each contributes to its pharmacological profile. Among the most important are inhibition of cyclic nucleotide PHOSPHODIESTERASES, antagonism of ADENOSINE RECEPTORS, and modulation of intracellular calcium handling.
  • CODEINE PHOSPHATE 30 mg/1 - An opioid analgesic related to MORPHINE but with less potent analgesic properties and mild sedative effects. It also acts centrally to suppress cough.

Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

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Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



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