Lansoprazole
Cvs Pharmacy
Human Otc Drug
NDC 69842-507Lansoprazole is a human otc drug labeled by 'Cvs Pharmacy'. National Drug Code (NDC) number for Lansoprazole is 69842-507. This drug is available in dosage form of Tablet, Orally Disintegrating, Delayed Release. The names of the active, medicinal ingredients in Lansoprazole drug includes Lansoprazole - 15 mg/1 . The currest status of Lansoprazole drug is Active.
Drug Information:
| Drug NDC: | 69842-507 |
| 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: | Lansoprazole |
| 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: | Lansoprazole |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cvs Pharmacy |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Orally Disintegrating, Delayed Release |
| 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: | LANSOPRAZOLE - 15 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: | NDA |
| 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: | 02 Dec, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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: | NDA208025 |
| 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: | CVS Pharmacy
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 351261
|
| 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. |
| NUI: | N0000175525
N0000000147
N0000009724
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 0K5C5T2QPG
|
| 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 MOA: | Proton Pump Inhibitors [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Proton Pump Inhibitor [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Inhibition Gastric Acid Secretion [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Inhibition Gastric Acid Secretion [PE]
Proton Pump Inhibitor [EPC]
Proton Pump Inhibitors [MoA]
|
| 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 |
|---|
| 69842-507-55 | 3 CARTON in 1 CARTON (69842-507-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | 02 Dec, 2017 | N/A | No |
| 69842-507-74 | 14 BLISTER PACK in 1 CARTON (69842-507-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | 04 Jan, 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 acid reducer
Product Elements:
Lansoprazole lansoprazole lansoprazole lansoprazole ascorbic acid cetyl alcohol silicon dioxide copovidone k25-31 crospovidone (15 mpa.s at 5%) hypromelloses maltitol mannitol meglumine cellulose, microcrystalline polysorbate 80 propylene glycol sodium stearyl fumarate sorbitol sucralose talc titanium dioxide triethyl citrate off white mottled 15
Indications and Usage:
Use ⢠treats frequent heartburn (occurs 2 or more days a week) ⢠not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
Warnings:
Warnings allergy alert: do not use if you are allergic to lansoprazole
Do Not Use:
Warnings allergy alert: do not use if you are allergic to lansoprazole
Dosage and Administration:
Directions ⢠adults 18 years of age and older ⢠this product is to be used once a day (every 24 hours), every day for 14 days ⢠it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-day course of treatment ⢠take 1 tablet before eating in the morning ⢠do not crush or chew tablets ⢠place the tablet on tongue; tablet disintegrates, with or without water. the tablets can also be swallowed whole with water. ⢠take every day for 14 days ⢠do not take more than 1 tablet a day ⢠do not use for more than 14 days unless directed by your doctor ⢠do not take this medicine with alcohol repeated 14-day course (if needed) ⢠you may repeat a 14-day course every 4 months ⢠do not take for more than 14 days or more often than every 4 months unless directed by a doctor ⢠children under 18 years of age: ask a doctor before use. heartburn in children may sometimes be caused by a s
Read more...erious condition.
Stop Use:
Stop use and ask a doctor if ⢠your heartburn continues or worsens ⢠you need to take this product for more than 14 days ⢠you need to take more than 1 course of treatment every 4 months ⢠you get diarrhea ⢠you develop a rash or joint pain 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).
Package Label Principal Display Panel:
Package/label principal display panel compare to the active ingredient in prevacid ® 24 hr treats frequent heartburn lansoprazole melts in your mouth dissolves without water delayed release orally disintegrating tablets 15 mg actual size acid reducer may take 1 to 4 days for full effect 24 hour strawberry flavor 42 tablets three 14-day courses of treatment meltech ⢠melts in your mouth lansoprazole image
Further Questions:
Questions or comments? 1-800-719-9260: weekdays 7:30 am to 5:00 pm est consumer information treats frequent heartburn lansoprazole delayed release orally disintegrating tablets 15 mg acid reducer ⢠may take 1 to 4 days for full effect please read the entire package insert before taking lansoprazole delayed release orally disintegrating tablets. save for future reference. how lansoprazole delayed release orally disintegrating tablets treats your frequent heartburn lansoprazole delayed release orally disintegrating tablets stops acid production at the source - the pumps that release acid into the stomach. lansoprazole delayed release orally disintegrating tablet is taken once a day (every 24 hours), every day for 14 days. what you can expect when taking lansoprazole delayed release orally disintegrating tablets frequent heartburn can occur anytime during the 24-hour period (day or night). take lansoprazole delayed release orally disintegrating tablets in the morning before eating. lansoprazole is clinically proven to treat frequent heartburn. although some people get complete relief of symptoms within 24 hours, it may take 1 to 4 days for full effect. make sure you take lansoprazole delayed release orally disintegrating tablets every day for 14 days to treat your frequent heartburn. who should take lansoprazole delayed release orally disintegrating tablets adults (18 years and older) with frequent heartburn - when you have heartburn 2 or more days a week. who should not take lansoprazole delayed release orally disintegrating tablets people who have one episode of heartburn a week or less, or who want immediate relief of heartburn. how to take lansoprazole delayed release orally disintegrating tablets 14-day course of treatment ⢠take 1 tablet before eating in the morning. ⢠do not crush or chew tablets. ⢠place the tablet on tongue; tablet disintegrates, with or without water. the tablets can also be swallowed whole with water. ⢠take every day for 14 days. ⢠do not take more than 1 tablet a day. ⢠do not use for more than 14 days unless directed by your doctor. ⢠do not take this medicine with alcohol. when to take lansoprazole delayed release orally disintegrating tablets again you may repeat a 14-day course of therapy every 4 months. when to talk to your doctor do not take for more than 14 days or more often than every 4 months unless directed by a doctor. warnings and when to ask your doctor allergy alert: do not use if you are allergic to lansoprazole 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. ask a doctor before use if you have ⢠liver disease ⢠had heartburn over 3 months. this may be a sign of a more serious condition. ⢠heartburn with lightheadedness, sweating or dizziness ⢠chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness ⢠frequent chest pain ⢠frequent wheezing, particularly with heartburn ⢠unexplained weight loss ⢠nausea or vomiting ⢠stomach pain ask a doctor or pharmacist before use if you are taking a prescription drug. acid reducers may interact with certain prescription drugs. stop use and ask a doctor if ⢠your heartburn continues or worsens ⢠you need to take this product for more than 14 days ⢠you need to take more than 1 course of treatment every 4 months ⢠you get diarrhea ⢠you develop a rash or joint pain if pregnant or breast-feeding, ask a health care 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). tips for managing heartburn ⢠avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables. ⢠eat slowly and do not eat big meals. ⢠do not eat late at night or just before bedtime. ⢠do not lie flat or bend over soon after eating. ⢠raise the head of your bed. ⢠wear loose-fitting clothing around your stomach. ⢠if you are overweight, lose weight. ⢠if you smoke, quit smoking. clinical studies prove that lansoprazole effectively treats frequent heartburn in three clinical studies, lansoprazole was shown to be significantly better than placebo in treating frequent heartburn. how lansoprazole delayed release orally disintegrating tablets is sold this medicine is available in 14 tablet, 28 tablet and 42 tablet sizes. these sizes contain one, two and three 14-day courses of treatment, respectively. do not use for more than 14 days in a row unless directed by your doctor. for the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months. for questions or comments about lansoprazole delayed release orally disintegrating tablets call 1-800-719-9260 weekdays 7:30 am to 5:00 pm est made in israel manufactured by: dexcel pharma technologies ltd 10 hakidma street, yokneam 2069200, israel :8u17400j3