Butalbital, Acetaminophen And Caffeine
NDC 10135-628

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 10135-628?
  5. Butalbital, Acetaminophen And Caffeine Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Butalbital, Acetaminophen And Caffeine is a ANDA-approved product labeled by Marlex Pharmaceuticals Inc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a blue product. This product entry covers the primary NDC 10135-628 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
10135-628
Proprietary Name:
Butalbital, Acetaminophen And Caffeine
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Marlex Pharmaceuticals Inc
Labeler Code:
10135
Product Label ID:
5f6997ee-45d5-4ef9-a829-a284a35a4e72
FDA Application Number: [6]
ANDA207118
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
04-01-2017
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I

Product Characteristics

Color(s):
BLUE (C48333 - LIGHT BLUE CAP AND BODY)
Shape:
CAPSULE (C48336)
Size(s):
22 MM
Imprint(s):
N;26
Score:
1

Code Structure Chart

Product Details

What is NDC 10135-628?

The NDC code 10135-628 is assigned by the FDA to the product Butalbital, Acetaminophen And Caffeine. This pharmaceutical product is labeled by Marlex Pharmaceuticals Inc and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 10135-628-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Butalbital, Acetaminophen, and Caffeine capsules, USP 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.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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: 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
  • RxCUI: 889520 - APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule

* Please review the full disclaimer at the bottom of this page.

Patient Education

Acetaminophen, Butalbital, and Caffeine


This combination of drugs is used to relieve tension headaches. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
[Learn More]


Pain Relievers


Pain relievers are medicines that reduce or relieve headaches, sore muscles, arthritis, or other aches and pains. There are many different pain medicines, and each one has advantages and risks. Some types of pain respond better to certain medicines than others. Each person may also have a slightly different response to a pain reliever.

Over-the-counter (OTC) medicines are good for many types of pain. There are two main types of OTC pain medicines: acetaminophen (Tylenol) and nonsteroidal anti-inflammatory drugs (NSAIDs). Aspirin, naproxen (Aleve), and ibuprofen (Advil, Motrin) are examples of OTC NSAIDs.

If OTC medicines don't relieve your pain, your doctor may prescribe something stronger. Many NSAIDs are also available at higher prescription doses. The most powerful pain relievers are opioids. They are very effective, but they can sometimes have serious side effects. There is also a risk of addiction. Because of the risks, you must use them only under a doctor's supervision.

There are many things you can do to help ease pain. Pain relievers are just one part of a pain treatment plan.


[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".