Famotidine
Cvs Pharmacy, Inc.
Human Otc Drug
NDC 69842-928Famotidine is a human otc drug labeled by 'Cvs Pharmacy, Inc.'. National Drug Code (NDC) number for Famotidine is 69842-928. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Famotidine drug includes Famotidine - 10 mg/1 . The currest status of Famotidine drug is Active.
Drug Information:
| Drug NDC: | 69842-928 |
| 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: | Famotidine |
| 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: | Famotidine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cvs Pharmacy, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film 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: | FAMOTIDINE - 10 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: | 28 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: | ANDA206531 |
| 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, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 199047
|
| 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: | N0000000151
N0000175784
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 5QZO15J2Z8
|
| 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: | Histamine H2 Receptor Antagonists [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: | Histamine-2 Receptor Antagonist [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: | 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 |
|---|
| 69842-928-84 | 1 BOTTLE in 1 CARTON (69842-928-84) / 30 TABLET, FILM COATED in 1 BOTTLE | 28 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 acid reducer
Product Elements:
Famotidine famotidine famotidine famotidine carnauba wax starch, corn hydroxypropyl cellulose (1600000 wamw) hypromellose 2910 (5 mpa.s) magnesium stearate microcrystalline cellulose ferric oxide red sodium starch glycolate type a corn talc titanium dioxide biconvex cc;58
Indications and Usage:
Uses 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 food and beverages
Warnings:
Warnings allergy alert: do not use if you are allergic to famotidine or other acid reducers
Do Not Use:
Warnings allergy alert: do not use if you are allergic to famotidine or other acid reducers
Dosage and Administration:
Directions adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor
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
Package Label Principal Display Panel:
Package label-principal display panel -10 mg (30 tablets container label) ?cvs health ® ndc 69842-928-84 original strength acid reducer famotidine tablets usp 10 mg prevents & relieves heartburn due to acid indigestion just one tablet! see new warnings 30 tablets package label-principal display panel -10 mg (30 tablets container label)
Package label-principal display panel -10 mg (30 tablets container carton label) ?cvs health ® compare to the active ingredient in original strength zantac 360°* ndc 69842-928-84 original strength new formula acid reducer famotidine tablets usp 10 mg just one tablet! prevents & relieves heartburn due to acid indigestion see new warnings actual size 30 tablets package label-principal display panel -10 mg (30 tablets container carton label)
Further Questions:
Questions or comments? call 1-855-274-4122 tips for managing heartburn do not lie flat or bend over after eating do not wear tight-fitting clothing around the stomach do not eat before bedtime raise the head of your bed avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables eat slowly and avoid big meals if overweight, lose weight quit smoking just one tablet prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages. do not use if carton is open or if printed foil seal under bottle cap is open or torn. distributed by: cvs pharmacy, inc. one cvs drive, woonsocket, ri 02895 © 2021 cvs/pharmacy cvs.com® 1-800-shop cvs made in india code: ts/drugs/22/2009