Meclizine
Meclizine Hcl 25mg
Bryant Ranch Prepack
Human Otc Drug
NDC 71335-1215Meclizine also known as Meclizine Hcl 25mg is a human otc drug labeled by 'Bryant Ranch Prepack'. National Drug Code (NDC) number for Meclizine is 71335-1215. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Meclizine drug includes Meclizine Hydrochloride - 25 mg/1 . The currest status of Meclizine drug is Active.
Drug Information:
| Drug NDC: | 71335-1215 |
| 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 |
| 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 Hcl 25mg |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bryant Ranch Prepack |
| 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: | 01 Feb, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 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. |
| 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: | Bryant Ranch Prepack
|
| 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 |
|---|
| 71335-1215-0 | 120 TABLET, CHEWABLE in 1 BOTTLE (71335-1215-0) | 20 May, 2019 | N/A | No |
| 71335-1215-1 | 30 TABLET, CHEWABLE in 1 BOTTLE (71335-1215-1) | 20 May, 2019 | N/A | No |
| 71335-1215-2 | 20 TABLET, CHEWABLE in 1 BOTTLE (71335-1215-2) | 20 May, 2019 | N/A | No |
| 71335-1215-3 | 25 TABLET, CHEWABLE in 1 BOTTLE (71335-1215-3) | 20 May, 2019 | N/A | No |
| 71335-1215-4 | 40 TABLET, CHEWABLE in 1 BOTTLE (71335-1215-4) | 20 May, 2019 | N/A | No |
| 71335-1215-5 | 60 TABLET, CHEWABLE in 1 BOTTLE (71335-1215-5) | 20 May, 2019 | N/A | No |
| 71335-1215-6 | 90 TABLET, CHEWABLE in 1 BOTTLE (71335-1215-6) | 20 May, 2019 | N/A | No |
| 71335-1215-7 | 8 TABLET, CHEWABLE in 1 BOTTLE (71335-1215-7) | 20 May, 2019 | N/A | No |
| 71335-1215-8 | 14 TABLET, CHEWABLE in 1 BOTTLE (71335-1215-8) | 20 May, 2019 | N/A | No |
| 71335-1215-9 | 10 TABLET, CHEWABLE in 1 BOTTLE (71335-1215-9) | 20 May, 2019 | 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 meclizine hcl 25mg meclizine hydrochloride meclizine croscarmellose sodium dextrose, unspecified form fd&c red no. 40 magnesium stearate microcrystalline cellulose silicon dioxide saccharin sodium stearic acid light pink color round tablet ph051
Indications and Usage:
Uses prevents and treats nausea, vomiting or dizziness associated with motion sickness
Warnings:
Warnings do not use for children under 12 years of age unless directed by a doctor. do not take unless directed by a doctor if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis do not take if you are taking sedatives or tranquilizers, without first consulting your doctor. when using this product do not exceed recommended dosage drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful 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.
When Using:
When using this product do not exceed recommended dosage drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions doage should be taken 1 hour before travel starts adults and children 12 years and over take 1 or 2 tablets once daily or as directed by doctor
How Supplied:
How supplied product: 71335-1215 ndc: 71335-1215-0 120 tablet, chewable in a bottle ndc: 71335-1215-1 30 tablet, chewable in a bottle ndc: 71335-1215-2 20 tablet, chewable in a bottle ndc: 71335-1215-3 25 tablet, chewable in a bottle ndc: 71335-1215-4 40 tablet, chewable in a bottle ndc: 71335-1215-5 60 tablet, chewable in a bottle ndc: 71335-1215-6 90 tablet, chewable in a bottle ndc: 71335-1215-7 8 tablet, chewable in a bottle ndc: 71335-1215-8 14 tablet, chewable in a bottle ndc: 71335-1215-9 10 tablet, chewable in a bottle
Package Label Principal Display Panel:
Meclizine 25mg chewable label image
Further Questions:
Questions? adverse drug event call (800) 687-0176 (m - f, 8am - 4pm est).