NDC Compounded Drug 73271-1218-1 Promethazine Hydrochloride
Cream Topical
Compounded Drug Product Information
| NDC Product Code | 73271-1218 |
| NDC Package Code | 73271-1218-1 |
| 11-Digit NDC Billing Format NDC Format for Billing For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration. |
73271121801 |
| Package Description | 1 mL in 1 SYRINGE |
| Product Type 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. |
Human Compounded Drug |
| Proprietary Name What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
Promethazine Hcl |
| Non-Proprietary Name 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. |
Promethazine Hcl |
| Substance Name 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. |
Promethazine Hydrochloride |
| Usage Information Product Usage Information The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs. |
See also Warning section. Promethazine is used to prevent and treat nausea and vomiting related to certain conditions (such as before/after surgery, motion sickness). It is also used to treat allergy symptoms such as rash, itching, and runny nose. It may be used to help you feel sleepy/relaxed before and after surgery or to help certain opioid pain relievers (such as meperidine) work better. It may also be used for a short time to treat a runny nose due to the common cold. Promethazine is an antihistamine and works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its other effects (such as anti-nausea, calming, pain relief) may work by affecting other natural substances (such as acetylcholine) and by acting directly on certain parts of the brain. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray). |
| Dosage Form | Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. |
| Route Name | Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL. |
| Marketing Category | OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS) |
| Labeler Code | 73271 |
| Labeler Name What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC. |
Right Value Drug Stores Llc Dba Carie Boyd's Prescription Shop |
| Substance Name | Promethazine Hydrochloride |
| Active Ingredients Information | 25 mg/1 mL |
| Reporting Period | 2023-1 |
Frequently Asked Questions
What is the NDC number assigned to Promethazine Hcl?
Promethazine Hcl was assigned by its manufacturer with NDC product code 73271-1218. This product is a drug classified as a human compounded drug. Compounded drugs are medications created by combining or altering existing drugs to meet the specific needs of certain patients. The NDC directory only includes information about compounded drugs from facilities that choose to assign NDC numbers to their products.
Which are the NDC package codes for Promethazine Hcl?
The NDC package code 73271-1218-1 was assigned to a 1 mL in 1 SYRINGE of promethazine hydrochloride administered topical via cream.
Who manufactures this product?
Promethazine Hcl is manufactured by an outsourced facility and labeled by Right Value Drug Stores Llc Dba Carie Boyd's Prescription Shop. All compounded drugs included in the NDC directory are classified as "Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)". Outsourcing facilities are a type of drug compounding facility regulated under Section 503B of the FD&C Act could be eligible for exemptions from drug registration if they meet all the conditions specified under Section 503B.
