Acidum Benzoicum
Hahnemann Laboratories, Inc.
Human Otc Drug
NDC 63545-428Acidum Benzoicum is a human otc drug labeled by 'Hahnemann Laboratories, Inc.'. National Drug Code (NDC) number for Acidum Benzoicum is 63545-428. This drug is available in dosage form of Pellet. The names of the active, medicinal ingredients in Acidum Benzoicum drug includes Benzoic Acid - 6 [hp_C]/1 . The currest status of Acidum Benzoicum drug is Active.
Drug Information:
| Drug NDC: | 63545-428 |
| 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: | Acidum Benzoicum |
| 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: | Acidum Benzoicum |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hahnemann Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Pellet |
| 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: | BENZOIC ACID - 6 [hp_C]/1
|
| 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: | 14 Apr, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 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. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Hahnemann Laboratories, 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: | N0000175806
N0000175807
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 8SKN0B0MIM
|
| 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: | Ammonium Ion Binding Activity [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: | Nitrogen Binding Agent [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: | Ammonium Ion Binding Activity [MoA]
Nitrogen Binding Agent [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 |
|---|
| 63545-428-01 | 200 PELLET in 1 VIAL, GLASS (63545-428-01) | 14 Apr, 2022 | N/A | No |
| 63545-428-02 | 1200 PELLET in 1 BOTTLE, GLASS (63545-428-02) | 14 Apr, 2022 | N/A | No |
| 63545-428-03 | 4000 PELLET in 1 BOTTLE, GLASS (63545-428-03) | 14 Apr, 2022 | 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:
Product Elements:
Acidum benzoicum acidum benzoicum sucrose benzoic acid benzoic acid acidum benzoicum acidum benzoicum sucrose benzoic acid benzoic acid acidum benzoicum acidum benzoicum sucrose benzoic acid benzoic acid acidum benzoicum acidum benzoicum sucrose benzoic acid benzoic acid acidum benzoicum acidum benzoicum sucrose benzoic acid benzoic acid acidum benzoicum acidum benzoicum sucrose benzoic acid benzoic acid acidum benzoicum acidum benzoicum sucrose benzoic acid benzoic acid acidum benzoicum acidum benzoicum sucrose benzoic acid benzoic acid
Indications and Usage:
Warnings:
Dosage and Administration:
Dosage Forms and Strength:
Package Label Principal Display Panel:
Acidum benzoicum 6c 5g acidum benzoicum 6c 30g acidum benzoicum 6c 100g acidum benzoicum 12c 5g acidum benzoicum 12c 30g acidum benzoicum 12c 100g acidum benzoicum 30c 1g acidum benzoicum 30c 5g acidum benzoicum 30c 30g acidum benzoicum 30c 100g acidum benzoicum 100c 1g acidum benzoicum 100c 5g acidum benzoicum 100c 30g acidum benzoicum 100c 100g acidum benzoicum 200c 1g acidum benzoicum 200c 5g acidum benzoicum 200c 30g acidum benzoicum 200c 100g acidum benzoicum 500c 1g acidum benzoicum 500c 5g acidum benzoicum 500c 30g acidum benzoicum 500c 100g acidum benzoicum 1m 1g acidum benzoicum 1m 5g acidum benzoicum 1m 30g acidum benzoicum 1m 100g acidum benzoicum 10m 1g acidum benzoicum 10m 5g acidum benzoicum 10m 30g acidum benzoicum 10m 100g
Further Questions: