Ferrous Sulfate
Richmond Pharmaceuticals, Inc.
Human Otc Drug
NDC 54738-963Ferrous Sulfate is a human otc drug labeled by 'Richmond Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Ferrous Sulfate is 54738-963. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Ferrous Sulfate drug includes Ferrous Sulfate - 325 mg/1 . The currest status of Ferrous Sulfate drug is Active.
Drug Information:
| Drug NDC: | 54738-963 |
| 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: | Ferrous Sulfate |
| 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: | Ferrous Sulfate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Richmond Pharmaceuticals, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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: | FERROUS SULFATE - 325 mg/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 DRUG OTHER |
| 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: | 01 Jun, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 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: | Richmond Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 310325
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 39R4TAN1VT
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 54738-963-01 | 100 TABLET in 1 BOTTLE (54738-963-01) | 01 Jun, 2015 | N/A | No |
| 54738-963-03 | 1000 TABLET in 1 BOTTLE (54738-963-03) | 01 Jun, 2015 | 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:
Purpose iron supplement
Product Elements:
Ferrous sulfate ferrous sulfate croscarmellose sodium dibasic calcium phosphate dihydrate fd&c red no. 40 fd&c yellow no. 6 hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycol 400 titanium dioxide ferrous sulfate ferrous cation
Indications and Usage:
Suggested use adults: one (1) tablet daily, preferably after meals or as directed by the doctor. children: as directed by the doctor.
Warnings:
Warning: accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. keep this product out of reach of children . in case of accidental overdose, call a doctor or poison control center immediately. warnings: do not exceed recommended dosage. the treatment of any anemic condition should be under the advice and supervision of doctor. occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. iron-containing medication may occasionally cause constipation or diarrhea. as with any drug, if you are pregnant or nursing baby, seek the advice of a health professional before using this product.
Dosage and Administration:
Dosage and administration each tablet contains: calcium 20 mg (2% daily value) store in a dry place at controlled room temperature at 15-30 °c (59°-86° f). do not expose to excessive heat or moisture.
Package Label Principal Display Panel:
Package label ferrous sulfate tablets 325 mg (5 gr) iron supplement ndc: 54738-963-01 â 100 tablets ndc: 54738-963-03 â 1000 tablets img_4683
Further Questions:
Questions or comments do not use if imprinted safety seal under cap is missing or damaged call 804-270-4498 monday-friday, 8.30 am â 4.30 pm et