Anti-diarrheal
Loperamide Hydrochloride
Bionpharma Inc.
Human Otc Drug
NDC 69452-266Anti-diarrheal also known as Loperamide Hydrochloride is a human otc drug labeled by 'Bionpharma Inc.'. National Drug Code (NDC) number for Anti-diarrheal is 69452-266. This drug is available in dosage form of Capsule, Liquid Filled. The names of the active, medicinal ingredients in Anti-diarrheal drug includes Loperamide Hydrochloride - 2 mg/1 . The currest status of Anti-diarrheal drug is Active.
Drug Information:
| Drug NDC: | 69452-266 |
| 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: | Anti-diarrheal |
| 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: | Loperamide Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bionpharma Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule, Liquid Filled |
| 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: | LOPERAMIDE HYDROCHLORIDE - 2 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: | NDA |
| 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: | 02 Aug, 2019 |
| 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. |
| Application Number: | NDA021855 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | Bionpharma Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 978006
|
| 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: | 77TI35393C
|
| 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: | Opioid Agonist [EPC]
Opioid Agonists [MoA]
|
| 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 |
|---|
| 69452-266-12 | 2 BLISTER PACK in 1 CARTON (69452-266-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 20 Mar, 2020 | 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 anti-diarrheal
Product Elements:
Anti-diarrheal loperamide hydrochloride butylated hydroxyanisole fd&c blue no. 1 gelatin glycerin glyceryl caprylate polyoxyl 40 hydrogenated castor oil water loperamide hydrochloride loperamide lp2
Indications and Usage:
Use controls symptoms of diarrhea, including travelers' diarrhea
Warnings:
Warnings allergy alert: do not use if you have ever had a rash or other allergic reaction to loperamide hcl heart alert: taking more than directed can cause serious heart problems or death
Do Not Use:
Warnings allergy alert: do not use if you have ever had a rash or other allergic reaction to loperamide hcl heart alert: taking more than directed can cause serious heart problems or death
When Using:
When using this product tiredness, drowsiness, or dizziness may occur. be careful when driving or operating machinery.
Dosage and Administration:
Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea. not for use in children under 12 years of age adults and children 12 years and over: 2 capsules after the first loose stool; 1 capsules after each subsequent loose stool; but no more than 4 capsules in 24 hours
Stop Use:
Stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. these may be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel ndc 69452-266-12 a+health compare to the active ingredient in imodium ® a-d loperamide hcl capsules, 2 mg anti-diarrheal controls the symptoms of diarrhea suitable for adults and children 12 years and over 24 softgels* *soft gelatin liquid-filled capsules each softgel contains 2 mg loperamide hcl carton
Further Questions:
Questions or comments? call toll free 1-888-235-2466 (mon - fri 9am - 5pm est)