Meclizine Hydrochloride
Preferred Pharmaceuticals Inc.
Human Otc Drug
NDC 68788-7873Meclizine Hydrochloride is a human otc drug labeled by 'Preferred Pharmaceuticals Inc.'. National Drug Code (NDC) number for Meclizine Hydrochloride is 68788-7873. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Meclizine Hydrochloride drug includes Meclizine Hydrochloride - 25 mg/1 . The currest status of Meclizine Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 68788-7873 |
| 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: | Meclizine Hydrochloride |
| 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: | Meclizine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Preferred Pharmaceuticals Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Chewable |
| 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: | MECLIZINE HYDROCHLORIDE - 25 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: | 19 Feb, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 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: | part336 |
| 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: | Preferred Pharmaceuticals Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 995632
|
| 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: | HDP7W44CIO
|
| 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: | Antiemetic [EPC]
Emesis Suppression [PE]
|
| 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 |
|---|
| 68788-7873-1 | 100 TABLET, CHEWABLE in 1 BOTTLE (68788-7873-1) | 19 Feb, 2021 | N/A | No |
| 68788-7873-2 | 30 TABLET, CHEWABLE in 1 BOTTLE (68788-7873-2) | 26 Aug, 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:
Purpose antiemetic
Product Elements:
Meclizine hydrochloride meclizine hydrochloride crospovidone vanilla bean magnesium stearate raspberry stearic acid fd&c red no. 40 meclizine hydrochloride meclizine lactose monohydrate saccharin sodium croscarmellose sodium silicon dioxide rosy 5172
Indications and Usage:
Uses prevents and treats nausea, vomiting or dizziness due to motion sickness
Warnings:
Do not use in children under 12 years of age unless directed by a doctor ask a doctor before use if you have ? glaucoma ? a breathing problem such as emphysema or chronic bronchitis ? trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product ? do not exceed recommended dosage ? may cause drowsiness ? alcohol, sedatives, and tranquilizers may increase drowsiness ? avoid alcoholic drinks ? use caution when driving a motor vehicle or operating machinery if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).
Do Not Use:
Do not use in children under 12 years of age unless directed by a doctor ask a doctor before use if you have ? glaucoma ? a breathing problem such as emphysema or chronic bronchitis ? trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product ? do not exceed recommended dosage ? may cause drowsiness ? alcohol, sedatives, and tranquilizers may increase drowsiness ? avoid alcoholic drinks ? use caution when driving a motor vehicle or operating machinery if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).
When Using:
When using this product ? do not exceed recommended dosage ? may cause drowsiness ? alcohol, sedatives, and tranquilizers may increase drowsiness ? avoid alcoholic drinks ? use caution when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions ? dosage should be taken one hour before travel starts adults and children 12 years of age and over chew 1 to 2 tablets once daily, or as directed by a doctor children under 12 years of age do not give this product to children under 12 years of age unless directed by a doctor
Overdosage:
In case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).
Package Label Principal Display Panel:
Rugby ndc 68788-7873 compare to the active ingredient in bonine®* meclizibe 25 mg antiemetic chewable tablets preferred pharmaceuticals inc. meclizine hcl 25mg chewable tablets
Further Questions:
Questions or comments? 1-800-645-2158