NDC 63545-700 Sinecch

Arnica Montana

NDC Product Code 63545-700

NDC Code: 63545-700

Proprietary Name: Sinecch 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.

Non-Proprietary Name: Arnica Montana 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.

Product Characteristics

Color(s):
ORANGE (C48331 - ORANGE/PEACH CAPSULES (1M STRENGTH))
PINK (C48328 - PEACH CAPSULES (12C STRENGTH))
Shape: CAPSULE (C48336)
Size(s):
20 MM
Score: 1

NDC Code Structure

  • 63545 - Hahnemann Laboratories, Inc. Dba Alpine Pharmaceuticals
    • 63545-700 - Sinecch

NDC 63545-700-02

Package Description: 1 BLISTER PACK in 1 BOX > 12 [hp_M] in 1 BLISTER PACK (63545-700-01)

NDC Product Information

Sinecch with NDC 63545-700 is a a human over the counter drug product labeled by Hahnemann Laboratories, Inc. Dba Alpine Pharmaceuticals. The generic name of Sinecch is arnica montana. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Hahnemann Laboratories, Inc. Dba Alpine Pharmaceuticals

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.

Sinecch 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.

  • ARNICA MONTANA 1 [hp_M]/[hp_M]

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SUCROSE (UNII: C151H8M554)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)

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: Hahnemann Laboratories, Inc. Dba Alpine Pharmaceuticals
Labeler Code: 63545
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 05-07-2019 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’.

* Please review the disclaimer below.

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