NDC 0527-1312 Butalbital, Aspirin, Caffeine And Codeine Phosphate
Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
BLUE (C48333)
Code Structure Chart
Product Details
What is NDC 0527-1312?
What are the uses for Butalbital, Aspirin, Caffeine And Codeine Phosphate?
What are Butalbital, Aspirin, Caffeine And Codeine Phosphate Active Ingredients?
- ASPIRIN 325 mg/1 - The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5)
- 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.
Which are Butalbital, Aspirin, Caffeine And Codeine Phosphate UNII Codes?
The UNII codes for the active ingredients in this product are:
- BUTALBITAL (UNII: KHS0AZ4JVK)
- BUTALBITAL (UNII: KHS0AZ4JVK) (Active Moiety)
- ASPIRIN (UNII: R16CO5Y76E)
- ASPIRIN (UNII: R16CO5Y76E) (Active Moiety)
- CAFFEINE (UNII: 3G6A5W338E)
- CAFFEINE (UNII: 3G6A5W338E) (Active Moiety)
- CODEINE PHOSPHATE (UNII: GSL05Y1MN6)
- CODEINE ANHYDROUS (UNII: UX6OWY2V7J) (Active Moiety)
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:
- D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
- ALUMINUM OXIDE (UNII: LMI26O6933)
- D&C RED NO. 33 (UNII: 9DBA0SBB0L)
- D&C RED NO. 28 (UNII: 767IP0Y5NH)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- GELATIN (UNII: 2G86QN327L)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- STARCH, CORN (UNII: O8232NY3SJ)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- STEARIC ACID (UNII: 4ELV7Z65AP)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
What is the NDC to RxNorm Crosswalk for Butalbital, Aspirin, Caffeine And Codeine Phosphate?
- 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
Which are the Pharmacologic Classes for Butalbital, Aspirin, Caffeine And Codeine Phosphate?
- Anti-Inflammatory Agents, Non-Steroidal - [CS]
- Barbiturate - [EPC] (Established Pharmacologic Class)
- Barbiturates - [CS]
- Central Nervous System Stimulant - [EPC] (Established Pharmacologic Class)
- Central Nervous System Stimulation - [PE] (Physiologic Effect)
- Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
- Decreased Platelet Aggregation - [PE] (Physiologic Effect)
- Decreased Prostaglandin Production - [PE] (Physiologic Effect)
- Full Opioid Agonists - [MoA] (Mechanism of Action)
- Methylxanthine - [EPC] (Established Pharmacologic Class)
- Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
- Opioid Agonist - [EPC] (Established Pharmacologic Class)
- Platelet Aggregation Inhibitor - [EPC] (Established Pharmacologic Class)
- Xanthines - [CS]
* Please review the disclaimer below.
[1] 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.
[2] What is the Substance Name? - 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.
[3] 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.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] 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.
[7] What is the Drug Enforcement Administration (DEA) CIII Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.
[8] 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.
[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".