NDC 73611-300 Qwo
Collagenase Clostridium Histolyticum-aaes Injection, Powder, Lyophilized, For Solution - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 73611 - Endo Aesthetics Llc
- 73611-300 - Qwo
Product Packages
NDC Code 73611-300-05
Package Description: 1 VIAL in 1 CARTON / 4 mL in 1 VIAL
NDC Code 73611-300-10
Package Description: 1 VIAL in 1 CARTON / 8 mL in 1 VIAL
Product Details
What is NDC 73611-300?
What are the uses for Qwo?
What are Qwo Active Ingredients?
- COLLAGENASE CLOSTRIDIUM HISTOLYTICUM .23 mg/mL - A metalloproteinase which degrades helical regions of native collagen to small fragments. Preferred cleavage is -Gly in the sequence -Pro-Xaa-Gly-Pro-. Six forms (or 2 classes) have been isolated from Clostridium histolyticum that are immunologically cross-reactive but possess different sequences and different specificities. Other variants have been isolated from Bacillus cereus, Empedobacter collagenolyticum, Pseudomonas marinoglutinosa, and species of Vibrio and Streptomyces. EC 3.4.24.3.
Which are Qwo UNII Codes?
The UNII codes for the active ingredients in this product are:
- COLLAGENASE CLOSTRIDIUM HISTOLYTICUM (UNII: 9X7O8V25IT)
- COLLAGENASE CLOSTRIDIUM HISTOLYTICUM (UNII: 9X7O8V25IT) (Active Moiety)
Which are Qwo 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:
- MANNITOL (UNII: 3OWL53L36A)
- SUCROSE (UNII: C151H8M554)
- TROMETHAMINE (UNII: 023C2WHX2V)
- HYDROCHLORIC ACID (UNII: QTT17582CB)
What is the NDC to RxNorm Crosswalk for Qwo?
- RxCUI: 2475863 - collagenase clostridium histolyticum-aaes 0.92 MG Injection
- RxCUI: 2475868 - Qwo 0.92 MG Injection
- RxCUI: 2475868 - collagenase clostridium histolyticum-aaes 0.92 MG Injection [Qwo]
- RxCUI: 2475870 - collagenase clostridium histolyticum-aaes 1.84 MG Injection
- RxCUI: 2475872 - Qwo 1.84 MG Injection
Which are the Pharmacologic Classes for Qwo?
* Please review the disclaimer below.
Patient Education
Collagenase Clostridium histolyticum Injection
Collagenase Clostridium histolyticum injection (Xiaflex) is used to treat Dupuytren's contracture (a painless thickening and tightening of tissue [cord] beneath the skin in the palm of the hand, which may make it difficult to straighten one or more fingers) when a cord of tissue can be felt upon examination. Collagenase Clostridium histolyticum injection (Xiaflex) is also used to treat Peyronie's disease (a thickening of tissue [plaque] inside the penis that causes the penis to curve). Collagenase Clostridium histolyticum injection (QWO) is also used to treat cellulite (fat deposit beneath the skin) in the buttocks of adult women. Collagenase Clostridium histolyticum injection is in a class of medications called enzymes. In people with Dupuytren's contracture, it works by helping to break down the cord of thickened tissue and allows the finger(s) to be straightened. In people with Peyronie's disease, it works by helping to break down the plaque of thickened tissue and allows the penis to be straightened. In women with cellulite, it works by releasing fibrous bands, redistributing fat cells, and stimulating the growth of new collagen.
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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.
[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.
[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
[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".