Meclizine Hcl
Meclizine Hydrochloride
Drug Ocean Llc
Human Otc Drug
NDC 70985-009Meclizine Hcl also known as Meclizine Hydrochloride is a human otc drug labeled by 'Drug Ocean Llc'. National Drug Code (NDC) number for Meclizine Hcl is 70985-009. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Meclizine Hcl drug includes Meclizine Hydrochloride - 12.5 mg/1 . The currest status of Meclizine Hcl drug is Active.
Drug Information:
| Drug NDC: | 70985-009 |
| 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 Hcl |
| 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: | Drug Ocean Llc |
| 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: | MECLIZINE HYDROCHLORIDE - 12.5 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: | 25 Jun, 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: | Drug Ocean LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 995624
|
| 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: | 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 |
|---|
| 70985-009-01 | 100 TABLET in 1 BOTTLE (70985-009-01) | 25 Jun, 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 antiemetic
Product Elements:
Meclizine hcl meclizine hydrochloride silicon dioxide crospovidone lactose monohydrate magnesium stearate microcrystalline cellulose meclizine hydrochloride meclizine white to off white ab;12
Indications and Usage:
Uses: prevents and treats nausea, vomiting, or dizziness due to motion sickness.
Warnings:
Warnings: do not take this product, unless directed by a doctor, if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland.
When Using:
When using 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 and over take 2 or 4 tablets once daily or as directed by a doctor
Package Label Principal Display Panel:
Principal display panel - 12.5 mg tablet label ndc 70985-009-01 meclizine hcl 12.5 mg 100 tablets distributed by: drug ocean llc, 221 river street, suite 9051, hoboken, nj 07030 manufactured by: unique pharmaceutical laboratories (a div. of j. b. chemicals & pharmaceuticals ltd.) mumbai 400 030, india org 05/21 principal display panel - 12.5 mg - 100 caplets principal display panel - 12.5 mg - 100 caplets
Further Questions:
Call 1-844-200-6566 monday to friday 9 am to 5 pm est