NDC 72850-0005 Decasilin

Poncirus Trifoliata Fruit, Peony Root, Platycodon Root

NDC Product Code 72850-0005

NDC 72850-0005-1

Package Description: 10 CAPSULE in 1 BLISTER PACK

NDC Product Information

Decasilin with NDC 72850-0005 is a a human over the counter drug product labeled by Chunwoo Pharmaceutical Co., Ltd.. The generic name of Decasilin is poncirus trifoliata fruit, peony root, platycodon root. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Chunwoo Pharmaceutical Co., Ltd.

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Otc Drug 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.

Decasilin Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PONCIRUS TRIFOLIATA FRUIT 17.12 1/1001
  • PAEONIA LACTIFLORA ROOT 22.95 1/1001
  • GINGER 5.82 1/1001
  • PLATYCODON GRANDIFLORUS ROOT 17.12 1/1001
  • JUJUBE FRUIT 17.12 1/1001
  • LICORICE 17.12 1/1001

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Chunwoo Pharmaceutical Co., Ltd.
Labeler Code: 72850
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Start Marketing Date: 10-19-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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Decasilin Product Label Images