NDC 84775-063-01 HUMAN OTC DRUG

Drug Status:  Deprecated

Proprietary Name: Hyaluronic Acid Freeze-dried Powder

Drug Overview

The NDC Code 84775-063-01 is assigned to “Hyaluronic Acid Freeze-dried Powder ” (also known as: “Hyaluronic Acid”), a human otc drug labeled by “Shenzhen Fusian Technology Co Ltd”. The product's dosage form is emulsion, and is administered via cutaneous form.

Disclaimer

Do not rely on DataLabs to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of FDA-regulated products. We may limit or otherwise restrict your access to the API/WEB in line with our Terms of Service.

Drug Information
NDC Package Code	84775-063-01
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Product NDC	84775-063
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
11 Digit NDC Code	84775-0063-01
	It should be noted that many NDCs are displayed on drug packaging in a 10-digit format. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.
Proprietary Name	Hyaluronic Acid Freeze-dried Powder
	Also known as the trade name. It is the name of the product chosen by the labeler.
Non Proprietary Name	Hyaluronic Acid
	Sometimes called the generic name, this is usually the active ingredient(s) of the product.
Product Type Name	HUMAN OTC DRUG
	Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Labeler Name	Shenzhen Fusian Technology Co Ltd
	Name of Company corresponding to the labeler code segment of the ProductNDC.
Status	Deprecated
	Possible status values: Active Active NDC Code Deprecated Deprecated NDC Code Unfinished (Unapproved) The following status describes submitted unfinished drugs, including the marketing categories of Active Pharmaceutical Ingredient (API), Drug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding. FDA does not review and approve unfinished products. Therefore, all products having "unfinished" status are considered unapproved.
Indication And Usage	Hyaluronic acid freeze-dried powder is a skin care product that mainly replenishes water and repairs, and is widely used to improve a variety of skin problems. The following are its main indications. 1. Dehydrated skin. Symptoms: The skin is dry, rough, and tight, and even peeling occurs. Functions: Hyaluronic acid freeze-dried powder can deeply replenish water, enhance the skin's moisturizing ability, and relieve dryness symptoms. 2. Damaged skin barrier. Symptoms: Skin is sensitive, red, swollen, and easily inflamed, and even tingling occurs, and the barrier function is weakened. Functions: Repair the skin barrier, promote the repair and regeneration of damaged skin, and improve the sensitive state. 3. Early fine lines and dry lines. Symptoms: Dry lines and superficial fine lines at the corners of the eyes and mouth caused by water loss. Functions: Replenish skin moisture, improve fine lines caused by dryness, and make the skin look smoother and more elastic. 4. Dull and dull skin. Symptoms: The skin is rough, lacks luster, and looks tired. Functions: Improve skin moisture, improve dullness, and restore skin translucency. 5. Skin with acne and acne marks Symptoms: Pigmentation and acne marks are left after acne heals, or the skin's ability to repair is weak. Function: Accelerates acne repair, helps fade acne marks, and promotes skin self-repair. 6. Sensitive skin Symptoms: Strong reaction to external stimuli (such as wind, temperature difference), prone to redness and fever. Function: Calms and soothes the skin, reduces irritation, and enhances skin tolerance. 7. Early aging skin Symptoms: Sagging and dry skin accompanied by loss of collagen, showing signs of aging. Function: Replenishes moisture and locks in moisture, while maintaining skin elasticity and delaying skin aging.
	A statement of each of the drug productÕs indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition.This field may also describe any relevant limitations of use.

Route & Dosage
Dosage Form Name	EMULSION
	The translation of the DosageForm Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Route Name	CUTANEOUS
	The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Pharmaceutical Classes	N/S (NOT SPECIFIED)
	These are the reported pharmaceutical class categories corresponding to the SubstanceNames listed above.

Substance & Strength
Substance Name	HYALURONIC ACID (Substance Adverse Reports) - 10 mg/50mg TREHALOSE (Substance Adverse Reports) - 10 mg/50mg WATER (Substance Adverse Reports) - 10 mg/50mg
	This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Drug Package Information
NDC Package Code	84775-063-01
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Package Description	50 MG IN 1 BOTTLE (84775-063-01)
	A description of the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. For example: 4 BOTTLES in 1 CARTON/100 TABLETS in 1 BOTTLE.
Sample Package	N
	Defines whether given package serves sample purposes.
Package NDC Exclude Flag	N
	This indicates whether the package has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.
Package Start Marketing Date	20241122
	This is the date that the labeler indicates was the start of its marketing of the drug package.
Package End Marketing Date	N/S (NOT SPECIFIED)
	This is the date the package will no longer be available on the market. If a package 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. Packages that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Packages with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Product Application & Marketing Information
Product NDC	84775-063
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Application Number	M016
	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.
Marketing Category Name	OTC MONOGRAPH DRUG
	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.
Listing Record Certified Through	20251231
	This is the date when the listing record will expire if not updated or certified by the firm.
Product Marketing Start Date	20241122
	This is the date that the labeler indicates was the start of its marketing of the drug product.
Product Marketing End Date	N/S (NOT SPECIFIED)
	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.
Product NDC Exclude Flag	N
	This 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.

Tracking Information
Last Update Date	2025-07-30
	The date that a record was last updated or changed.