NDC 70408-185 Promethazine Hydrochloride And Codeine Phosphate
Solution Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 70408 - Nostrum Laboratories, Inc.
- 70408-185 - Promethazine Hydrochloride And Codeine Phosphate
Product Characteristics
Product Packages
NDC Code 70408-185-31
Package Description: 118 mL in 1 BOTTLE
Product Details
What is NDC 70408-185?
What are the uses for Promethazine Hydrochloride And Codeine Phosphate?
What are Promethazine Hydrochloride And Codeine Phosphate Active Ingredients?
- CODEINE PHOSPHATE 10 mg/5mL - An opioid analgesic related to MORPHINE but with less potent analgesic properties and mild sedative effects. It also acts centrally to suppress cough.
- PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL - A phenothiazine derivative with histamine H1-blocking, antimuscarinic, and sedative properties. It is used as an antiallergic, in pruritus, for motion sickness and sedation, and also in animals.
Which are Promethazine Hydrochloride And Codeine Phosphate UNII Codes?
The UNII codes for the active ingredients in this product are:
- PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I)
- PROMETHAZINE (UNII: FF28EJQ494) (Active Moiety)
- CODEINE PHOSPHATE (UNII: GSL05Y1MN6)
- CODEINE ANHYDROUS (UNII: UX6OWY2V7J) (Active Moiety)
Which are Promethazine Hydrochloride 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:
- ASCORBIC ACID (UNII: PQ6CK8PD0R)
- CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
- D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
- EDETATE DISODIUM (UNII: 7FLD91C86K)
- ALCOHOL (UNII: 3K9958V90M)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- GLYCERIN (UNII: PDC6A3C0OX)
- METHYLPARABEN (UNII: A2I8C7HI9T)
- WATER (UNII: 059QF0KO0R)
- SODIUM BENZOATE (UNII: OJ245FE5EU)
- SODIUM CITRATE (UNII: 1Q73Q2JULR)
- SUCRALOSE (UNII: 96K6UQ3ZD4)
- SUCROSE (UNII: C151H8M554)
What is the NDC to RxNorm Crosswalk for Promethazine Hydrochloride And Codeine Phosphate?
- RxCUI: 991486 - codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution
- RxCUI: 991486 - codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution
- RxCUI: 991486 - codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral Syrup
Which are the Pharmacologic Classes for Promethazine Hydrochloride And Codeine Phosphate?
* Please review the disclaimer below.
Patient Education
Codeine
Codeine is used to relieve mild to moderate pain. It is also used, usually in combination with other medications, to reduce coughing. Codeine will help relieve symptoms but will not treat the cause of symptoms or speed recovery. Codeine belongs to a class of medications called opiate (narcotic) analgesics and to a class of medications called antitussives. When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain. When codeine is used to reduce coughing, it works by decreasing the activity in the part of the brain that causes coughing. Codeine is also available in combination with acetaminophen (Capital and Codeine, Tylenol with Codeine), aspirin, carisoprodol, and promethazine and as an ingredient in many cough and cold medications. This monograph only includes information about the use of codeine. If you are taking a codeine combination product, be sure to read information about all the ingredients in the product you are taking and ask your doctor or pharmacist for more information.
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Promethazine
Promethazine is used to relieve the symptoms of allergic reactions such as allergic rhinitis (runny nose and watery eyes caused by allergy to pollen, mold or dust), allergic conjunctivitis (red, watery eyes caused by allergies), allergic skin reactions, and allergic reactions to blood or plasma products. Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. Promethazine is also used to prevent and control nausea and vomiting that may occur after surgery, and with other medications to help relieve pain after surgery. Promethazine is also used to prevent and treat motion sickness. Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. Promethazine is in a class of medications called phenothiazines. It works by blocking the action of a certain natural substance in the body.
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* 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) CV 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".