NDC 10135-628 Butalbital, Acetaminophen And Caffeine

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
10135-628
Proprietary Name:
Butalbital, Acetaminophen And Caffeine
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Marlex Pharmaceuticals Inc
Labeler Code:
10135
Start Marketing Date: [9]
04-01-2017
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

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

Product Packages

NDC Code 10135-628-01

Package Description: 100 CAPSULE in 1 BOTTLE

Product Details

What is NDC 10135-628?

The NDC code 10135-628 is assigned by the FDA to the product Butalbital, Acetaminophen And Caffeine which is product labeled by Marlex Pharmaceuticals Inc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 10135-628-01 100 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, Acetaminophen And Caffeine?

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 Butalbital, Acetaminophen And Caffeine UNII Codes?

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

Which are Butalbital, Acetaminophen And Caffeine 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, Acetaminophen And Caffeine?

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 disclaimer below.

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.
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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 disclaimer below.

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".