Ranitidine
Wockhardt Usa Llc.
Human Otc Drug
NDC 64679-741Ranitidine is a human otc drug labeled by 'Wockhardt Usa Llc.'. National Drug Code (NDC) number for Ranitidine is 64679-741. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Ranitidine drug includes Ranitidine Hydrochloride - 150 mg/1 . The currest status of Ranitidine drug is Active.
Drug Information:
| Drug NDC: | 64679-741 |
| 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: | Ranitidine |
| 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: | Ranitidine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Wockhardt Usa Llc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Coated |
| 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: | RANITIDINE HYDROCHLORIDE - 150 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: | ANDA |
| 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: | 26 Nov, 2007 |
| 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: | ANDA078653 |
| 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: | Wockhardt USA LLC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198191
|
| 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: | BK76465IHM
|
| 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 H2 Receptor Antagonists [MoA]
Histamine-2 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 |
|---|
| 64679-741-00 | 30000 TABLET, COATED in 1 DRUM (64679-741-00) | 26 Nov, 2007 | N/A | No |
| 64679-741-01 | 1 BOTTLE in 1 CARTON (64679-741-01) / 10 TABLET, COATED in 1 BOTTLE | 26 Nov, 2007 | N/A | No |
| 64679-741-02 | 1 BOTTLE in 1 CARTON (64679-741-02) / 100 TABLET, COATED in 1 BOTTLE | 26 Nov, 2007 | N/A | No |
| 64679-741-03 | 10 BLISTER PACK in 1 CARTON (64679-741-03) / 10 TABLET, COATED in 1 BLISTER PACK | 26 Nov, 2007 | N/A | No |
| 64679-741-05 | 1 BOTTLE in 1 CARTON (64679-741-05) / 500 TABLET, COATED in 1 BOTTLE | 26 Nov, 2007 | N/A | No |
| 64679-741-06 | 6000 TABLET, COATED in 1 POUCH (64679-741-06) | 26 Nov, 2007 | 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:
Otc - purpose section acid reducer
Product Elements:
Ranitidine ranitidine ranitidine hydrochloride ranitidine cellulose, microcrystalline croscarmellose sodium diethyl phthalate fd&c yellow no. 6 ferric oxide red hypromellose 2910 (5 mpa.s) magnesium stearate silicon dioxide titanium dioxide orange colored film coated w741
Indications and Usage:
Use relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
Warnings:
Warnings allergy alert : do not use if you are allergic to ranitidine or other acid reducers do not use ? if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. these may be signs of a serious condition. see your doctor. ? with other acid reducers ? if you have kidney disease, except under the advice and supervision of a doctor ask a doctor before use if you have o frequent chest pain o frequent wheezing, particularly with heartburn o unexplained weight loss o nausea or vomiting o stomach pain o had heartburn over 3 months. this may be a sign of a more serious condition. o heartburn with lightheadedness, sweating or dizziness o chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness stop use and ask a doctor if o your heartburn continues or worsens o you need to take this product for more than 14 days pregnancy or breast feeding if pregnant or breast-feeding , ask a health profes
Read more...sional before use.
Dosage and Administration:
Directions ? adults and children 12 years and over: ? to relieve symptoms, swallow 1 tablet with a glass of water ? to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn ? can be used up to twice daily (do not take more than 2 tablets in 24 hours) ? children under 12 years: ask a doctor
Package Label Principal Display Panel:
Package label.principal display panel ranitidine tablets usp, 150 mg (otc) 150 mg - acid reducer 64679-741-06 label 150 mg
Further Questions:
Questions or comments call 1-800-346-6854 read the directions, consumer information leaflet and warnings before use. keep the carton. it contains important information. manufactured by: wockhardt limited, mumbai, india. distributed by: wockhardt usa llc. 20 waterview blvd. parsippany, nj 07054 usa. iss.020410