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  4. NDC Product Code: 54868-1037 Butalbital, Aspirin, Caffeine And Codeine Phosphate

NDC 54868-1037 Butalbital, Aspirin, Caffeine And Codeine Phosphate

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-1037?
  5. Butalbital, Aspirin, Caffeine And Codeine Phosphate Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
54868-1037
Proprietary Name:
Butalbital, Aspirin, Caffeine And Codeine Phosphate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
787cda7d-7aa4-4909-8e5c-f2fcf68828e4
Start Marketing Date: [9]
06-02-1998
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333)
YELLOW (C48330)
Shape:
CAPSULE (C48336)
Size(s):
22 MM
Imprint(s):
WATSON;3546
Score:
1

Code Structure Chart

Product Details

What is NDC 54868-1037?

The NDC code 54868-1037 is assigned by the FDA to the product Butalbital, Aspirin, Caffeine And Codeine Phosphate which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 54868-1037-1 20 capsule in 1 bottle , 54868-1037-3 30 capsule in 1 bottle , 54868-1037-4 120 capsule in 1 bottle , 54868-1037-5 60 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 and RxNorm crosswalk.

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

Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.Evidence supporting the efficacy of butalbital, aspirin, caffeine, and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: butalbital, aspirin, caffeine, and codeine phosphate capsules; codeine; Butalbital, Aspirin, and Caffeine Capsules, USP; and placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. Butalbital, aspirin, caffeine, and codeine phosphate capsules proved statistically significantly superior to each of its components (Butalbital, Aspirin, and Caffeine Capsules, USP and codeine) and to placebo on measures of pain relief.Evidence supporting the efficacy and safety of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.

Which are Butalbital, Aspirin, Caffeine And Codeine Phosphate UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Butalbital, Aspirin, 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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Butalbital, Aspirin, Caffeine And Codeine Phosphate?

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: 994237 - butalbital 50 MG / aspirin 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule
  • RxCUI: 994237 - aspirin 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule
  • RxCUI: 994237 - ASA 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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] 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".