| Drug NDC: | 43853-0017 |
| 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: | Estrogen And Progesterone |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| 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: | Agnus Castus, Angelica Sinensis, Apis Mellifica, Arnica Montana, Cimicifuga Racemosa, Estradiol, Estriol, Folliculinum, Galium Aparine, Glycyrrhiza Glabra, Korean Ginseng, Oophorinum (suis), Progesterone, Sepia, Thuja Occidentalis, Viscum Album |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Problen |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Spray |
| 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: | ANGELICA SINENSIS ROOT - 3 [hp_X]/mL APIS MELLIFERA - 6 [hp_X]/mL ARNICA MONTANA - 6 [hp_X]/mL ASIAN GINSENG - 3 [hp_X]/mL BLACK COHOSH - 3 [hp_X]/mL CHASTE TREE - 3 [hp_X]/mL ESTRADIOL - 9 [hp_C]/mL ESTRIOL - 9 [hp_C]/mL ESTRONE - 9 [hp_C]/mL GALIUM APARINE - 3 [hp_X]/mL Load more... GLYCYRRHIZA GLABRA - 3 [hp_X]/mL PROGESTERONE - 6 [hp_X]/mL SEPIA OFFICINALIS JUICE - 30 [hp_C]/mL SUS SCROFA OVARY - 30 [hp_C]/mL THUJA OCCIDENTALIS LEAFY TWIG - 6 [hp_X]/mL VISCUM ALBUM FRUITING TOP - 3 [hp_X]/mL |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | ORAL |
| 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: | 12 Jan, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 15 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: | ProBLEN |
| 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: | N0000185021 N0000175629 N0000184306 N0000185001 M0000728 M0002274 M0447348 N0000175825 N0000000100 N0000185371 N0000185375 M0006342 M0016962 M0017672 N0000175601 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | B66F4574UG 7S82P3R43Z O80TY208ZW CUQ3A77YXI K73E24S6X9 433OSF3U8A 4TI98Z838E FB33469R8E 2DI9HA706A Z4B6561488 Load more... 2788Z9758H 4G7DS2Q64Y QDL83WN8C2 S7YTV04R8O 1NT28V9397 BK9092J5MP |
| 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 MOA: | Estrogen Receptor Agonists [MoA] |
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. | |
| Pharmacologic Class EPC: | Standardized Insect Venom Allergenic Extract [EPC] Estrogen [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [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 PE: | Increased Histamine Release [PE] Cell-mediated Immunity [PE] Increased IgG Production [PE] |
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. | |
| Pharmacologic Class CS: | Allergens [CS] Bee Venoms [CS] Estradiol Congeners [CS] Dietary Proteins [CS] Plant Proteins [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: | Allergens [CS] Bee Venoms [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Estradiol Congeners [CS] Estrogen Receptor Agonists [MoA] Estrogen [EPC] Increased Histamine Release [PE] Increased IgG Production [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Progesterone [CS] Progesterone [EPC] Standardized Insect Venom Allergenic Extract [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 |
|---|---|---|---|---|
| 43853-0017-2 | 1 BOTTLE, SPRAY in 1 CARTON (43853-0017-2) / 30 mL in 1 BOTTLE, SPRAY (43853-0017-1) | 12 Jan, 2017 | 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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