| Drug NDC: | 63479-0109 |
| 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: | A09 Female Balance |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | A09 |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | FEMALE BALANCE |
| 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: | Argentum Nitricum, Atropinum Sulphuricum, Aurum Muriaticum Natronatum, Bos Taurus Ovary, Bos Taurus Pancreas, Bos Taurus Pituitarum Posterium, Bos Taurus Uterus, Cimicifuga Racemosa, Estrone, Helonias Dioica, Progesterone, Pulsatilla Vulgaris, Sabina, Sepia, Sequoiadendron Giganteum Whole, Sus Scrofa Pineal Gland, Sus Scrofa Spleen, Thiosinaminum, Thyroidinum, Viburnum Opulus |
| 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: | ALLYLTHIOUREA - 8 [hp_X]/mL ATROPINE SULFATE - 10 [hp_X]/mL BLACK COHOSH - 10 [hp_X]/mL BOS TAURUS OVARY - 7 [hp_C]/mL BOS TAURUS PANCREAS - 7 [hp_C]/mL BOS TAURUS PITUITARY GLAND - 9 [hp_C]/mL BOS TAURUS UTERUS - 7 [hp_C]/mL CHAMAELIRIUM LUTEUM ROOT - 8 [hp_X]/mL ESTRONE - 9 [hp_C]/mL JUNIPERUS SABINA LEAFY TWIG - 12 [hp_X]/mL Load more... PROGESTERONE - 9 [hp_C]/mL PULSATILLA VULGARIS - 10 [hp_C]/mL SEPIA OFFICINALIS JUICE - 30 [hp_X]/mL SEQUOIADENDRON GIGANTEUM WHOLE - 9 [hp_X]/mL SILVER NITRATE - 9 [hp_X]/mL SODIUM TETRACHLOROAURATE - 12 [hp_X]/mL SUS SCROFA PINEAL GLAND - 9 [hp_C]/mL SUS SCROFA SPLEEN - 7 [hp_C]/mL THYROID, UNSPECIFIED - 7 [hp_C]/mL VIBURNUM OPULUS BARK - 8 [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 Aug, 1988 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 22 Jun, 2026 |
| 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. | |
| NUI: | M0017672 N0000175601 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 706IDJ14B7 03J5ZE7KA5 K73E24S6X9 66LZN1C747 1M529TNT1D 7JM57I419K 9169LW451G DQV54Y5H3U 2DI9HA706A Z5BEX9K2G1 Load more... 4G7DS2Q64Y I76KB35JEV QDL83WN8C2 6CO90XQD9O 95IT3W8JZE 7FT6QUT299 050QZ2EDK7 92AMN5J79Y 0B4FDL9I6P T1UG6H6805 |
| 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. | |
| Pharmacologic Class EPC: | Progesterone [EPC] |
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. | |
| Pharmacologic Class CS: | Progesterone [CS] |
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. | |
| Pharmacologic Class: | Anticholinergic [EPC] Cholinergic Antagonists [MoA] Cholinergic Muscarinic Antagonist [EPC] Cholinergic Muscarinic Antagonists [MoA] Progesterone [CS] Progesterone [EPC] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 63479-0109-1 | 30 mL in 1 BOTTLE, GLASS (63479-0109-1) | 15 Aug, 1988 | 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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