NDC 54868-2088 Promethazine Hydrochloride

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:
Proprietary Name:
Promethazine Hydrochloride
Product Type: [3]
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
Start Marketing Date: [9]
Listing Expiration Date: [11]
Exclude Flag: [12]
Code Structure:
Code Navigator:

Product Packages

NDC Code 54868-2088-0

Package Description: 25 AMPULE in 1 CARTON / 1 mL in 1 AMPULE

Product Details

What is NDC 54868-2088?

The NDC code 54868-2088 is assigned by the FDA to the product Promethazine Hydrochloride which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54868-2088-0 25 ampule in 1 carton / 1 ml in 1 ampule. 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 Promethazine Hydrochloride?

Promethazine hydrochloride injection is indicated for the following conditions: Amelioration of allergic reactions to blood or plasma.In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.For other uncomplicated allergic conditions of the immediate type when oral therapy is  impossible or contraindicated.For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.Active treatment of motion sickness.Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.As an adjunct to analgesics for the control of postoperative pain.Preoperative, postoperative, and obstetric (during labor) sedation.Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia. 

Which are Promethazine Hydrochloride UNII Codes?

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

Which are Promethazine Hydrochloride 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 Promethazine Hydrochloride?

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:

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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".