Hgh
Human Growth Hormone
Problen
Human Otc Drug
NDC 43853-0023Hgh also known as Human Growth Hormone is a human otc drug labeled by 'Problen'. National Drug Code (NDC) number for Hgh is 43853-0023. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Hgh drug includes Somatropin - 30 [hp_X]/30mL . The currest status of Hgh drug is Active.
Drug Information:
| Drug NDC: | 43853-0023 |
| 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: | Hgh |
| 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: | Human Growth Hormone |
| 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: | Liquid |
| 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: | SOMATROPIN - 30 [hp_X]/30mL
|
| 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 Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| 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: | 09 May, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 03 May, 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. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| 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: | N0000175606
M0028842
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | NQX9KB6PCL
|
| 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: | Recombinant Human Growth Hormone [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: | Human Growth Hormone [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: | Human Growth Hormone [CS]
Recombinant Human Growth Hormone [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 43853-0023-1 | 30 mL in 1 BOTTLE (43853-0023-1) | 09 May, 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. |
Purpose:
Temporarily supports the body to rebalance human growth hormone (hgh) output. symptoms of imbalanced hgh may include: poor muscle/fat balance, dry wrinkled-looking skin, low energy, sleeplessness, weak immune system.*
Product Elements:
Hgh human growth hormone alcohol water somatropin somatropin
Indications and Usage:
Uses: temporarily supports the body to rebalance human growth hormone (hgh) output. symptoms of imbalanced hgh may include: poor muscle/fat balance, dry wrinkled-looking skin, low energy, sleeplessness, weak immune system.*
Warnings:
Warnings: not for use on children. if symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician. as with all medicines, if you are pregnant or breast feeding, consult a health professional before using this product. keep out of the reach of children. in case of overdose, get medical help or contact a poison control center right away. keep out of the reach of children.
Dosage and Administration:
Directions: adults: hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day. some people notice improvement within two or three weeks, others take longer.
Package Label Principal Display Panel:
Ndc: 43853-0023-1 hgh homeopathic organotherapy 1.0 fl oz (30ml) 20% alcohol problenopathy 1 oz. bottle label temporarily supports the body to rebalance human growth hormone (hgh) output. symptoms of imbalanced hgh may include: poor muscle/fat balance, dry wrinkled-looking skin, low energy, sleeplessness, weak immune system.*
Further Questions:
Distributed by: problen (888) 326-2121 3021 ridge rd., rockwall, tx 75032 questions or comments: www.problen.com