| Drug NDC: | 63479-0402 |
| 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. | |
| Proprietary Name: | D02 Digestive Drainage |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | D02 |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | DIGESTIVE DRAINAGE |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. | |
| Product Type: | 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. | |
| Non Proprietary Name: | Aloe, Activated Charcoal, Colchicum Autumnale Bulb, Collinsonia Canadensis Root, Cucurbita Pepo Flower, Dryopteris Filix-mas Root, Indole, Skim Milk, Lycopodium Clavatum Spore, Achillea Millefolium, Sodium Sulfate, Frangula Purshiana Bark, Scrophularia Nodosa, Skatole, Taraxacum Officinale, Tartaric Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Apex Energetics Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Solution/ Drops |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. | |
| Substance Name: | ACHILLEA MILLEFOLIUM - 1 [hp_X]/mL ACTIVATED CHARCOAL - 30 [hp_X]/mL ALOE - 2 [hp_X]/mL COLCHICUM AUTUMNALE BULB - 12 [hp_X]/mL COLLINSONIA CANADENSIS ROOT - 4 [hp_X]/mL CUCURBITA PEPO FLOWER - 2 [hp_X]/mL DRYOPTERIS FILIX-MAS ROOT - 8 [hp_X]/mL FRANGULA PURSHIANA BARK - 1 [hp_X]/mL INDOLE - 15 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 12 [hp_X]/mL Load more... SCROPHULARIA NODOSA - 9 [hp_X]/mL SKATOLE - 30 [hp_X]/mL SKIM MILK - 10 [hp_X]/mL SODIUM SULFATE - 30 [hp_X]/mL TARAXACUM OFFICINALE - 6 [hp_X]/mL TARTARIC ACID - 6 [hp_X]/mL |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | SUBLINGUAL |
| 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. | |
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. | |
| Marketing Start Date: | 15 Mar, 1993 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 24 Dec, 2025 |
| 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. | |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Apex Energetics Inc. |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. | |
| Original Packager: | Yes |
| Whether or not the drug has been repackaged for distribution. | |
| UNII: | 2FXJ6SW4PK 2P3VWU3H10 V5VD430YW9 993QHL78E6 O2630F3XDR 413MGP37HQ C0ZK0RRF5X 4VBP01X99F 8724FJW4M5 C88X29Y479 Load more... 7H443NUB2T 9W945B5H7R 6A001Y4M5A 0YPR65R21J 39981FM375 W4888I119H |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 63479-0402-1 | 30 mL in 1 BOTTLE, GLASS (63479-0402-1) | 15 Mar, 1993 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. | ||||
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