Chlorpheniramine Maleate 4 Mg
Chlorpheniramine Maleate
Pd-rx Pharmaceuticals, Inc.
Human Otc Drug
NDC 72789-134Chlorpheniramine Maleate 4 Mg also known as Chlorpheniramine Maleate is a human otc drug labeled by 'Pd-rx Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Chlorpheniramine Maleate 4 Mg is 72789-134. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Chlorpheniramine Maleate 4 Mg drug includes Chlorpheniramine Maleate - 4 mg/1 . The currest status of Chlorpheniramine Maleate 4 Mg drug is Active.
Drug Information:
| Drug NDC: | 72789-134 |
| 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: | Chlorpheniramine Maleate 4 Mg |
| 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: | Chlorpheniramine Maleate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pd-rx 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: | CHLORPHENIRAMINE MALEATE - 4 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: | OTC MONOGRAPH FINAL |
| 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 Nov, 2015 |
| 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: | part341 |
| 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: | PD-Rx Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1363309
|
| 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. |
| UNII: | V1Q0O9OJ9Z
|
| 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: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [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 |
|---|
| 72789-134-24 | 24 TABLET in 1 BOTTLE, PLASTIC (72789-134-24) | 26 Mar, 2021 | 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 antihistamine
Product Elements:
Chlorpheniramine maleate 4 mg chlorpheniramine maleate croscarmellose sodium calcium phosphate, dibasic, anhydrous magnesium stearate cellulose, microcrystalline starch, pregelatinized corn silicon dioxide chlorpheniramine maleate chlorpheniramine d&c yellow no. 10 ap;016
Indications and Usage:
Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose sneezing itchy nose or throat itchy, watery eyes
Warnings:
Warnings ask a doctor before use if you have glaucoma trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis
General Precautions:
When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children drug facts continued on back of label
Dosage and Administration:
Directions adults and children 12 years and over take 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours children 6 years to under 12 years take 1/2 tablet every 4 to 6 hours, not more than 3 tablets in 24 hours children under 6 years do not use
How Supplied:
16 how supplied chlorpheniramine maleatetablets are available as follows: 4 mg: yellow, round, scored tablet, debossed "heart. available in bottles of 24 tablets (ndc 72789-134-24)
Package Label Principal Display Panel:
Chlorpheniramine maleate 4mg antihistamine image
Further Questions:
Questions or comments? call 516-341-0666, 8:30 am - 4:30 pm et, monday - friday