Esomeprazole Magnesium
Retail Business Services, Llc.
Human Otc Drug
NDC 72476-500Esomeprazole Magnesium is a human otc drug labeled by 'Retail Business Services, Llc.'. National Drug Code (NDC) number for Esomeprazole Magnesium is 72476-500. This drug is available in dosage form of Capsule, Delayed Release. The names of the active, medicinal ingredients in Esomeprazole Magnesium drug includes Esomeprazole Magnesium Dihydrate - 20 mg/1 . The currest status of Esomeprazole Magnesium drug is Active.
Drug Information:
| Drug NDC: | 72476-500 |
| 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: | Esomeprazole Magnesium |
| 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: | Esomeprazole Magnesium |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Retail Business Services, Llc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule, 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: | ESOMEPRAZOLE MAGNESIUM DIHYDRATE - 20 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: | 16 Oct, 2017 |
| 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: | ANDA209339 |
| 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: | Retail Business Services, LLC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 606726
|
| 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: | 36H71644EQ
|
| 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: | Cytochrome P450 2C19 Inhibitors [MoA]
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 |
|---|
| 72476-500-03 | 3 BOTTLE in 1 CARTON (72476-500-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 16 Oct, 2017 | N/A | No |
| 72476-500-05 | 1 BOTTLE in 1 CARTON (72476-500-05) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 16 Oct, 2017 | 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:
Esomeprazole magnesium esomeprazole magnesium esomeprazole magnesium dihydrate esomeprazole silicon dioxide fd&c blue no. 1 gelatin, unspecified hydroxypropyl cellulose, unspecified hypromellose, unspecified magnesium carbonate magnesium oxide methacrylic acid - ethyl acrylate copolymer (1:1) type a glyceryl monostearate polysorbate 80 propylene glycol shellac sodium lauryl sulfate ammonia dextrose, unspecified form starch, corn sucrose talc titanium dioxide triethyl citrate ferric oxide yellow i81
Indications and Usage:
Uses 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 esomeprazole
Do Not Use:
Warnings allergy alert: do not use if you are allergic to esomeprazole
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 may take 1 to 4 days for full effect 14-day course of treatment swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. do not crush or chew capsules. do not use for more than 14 days unless directed by your doctor repeated 14-day courses (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 serious condition. other information read the directions and warnings before use keep the carton. it contains important information. store at 20-25°c (68-77°f) meets usp dissolution test 2
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.
Package Label Principal Display Panel:
Package label-principal display panel - 20 mg (14 capsules container label) careone ® ndc 72476-500-05 esomeprazole magnesium delayed-release capsules usp 20 mg* acid reducer 24 hr treats frequent heartburn may take 1 to 4 days for full effect one 14-day course of treatment 14 capsules package label-principal display panel - 20 mg (14 capsule container label)
Package label-principal display panel - 20 mg (14 capsules container carton) careone ® ndc 72476-500-05 compare to the active ingredient in nexium ® 24 hr see new warning information esomeprazole magnesium delayed-release capsules usp 20 mg* acid reducer 24 hr treats frequent heartburn may take 1 to 4 days for full effect capsules actual size 14 capsules one 14-day course of treatment package label-principal display panel - 20 mg (14 capsules container carton)
Package label-principal display panel - 20 mg (42 capsules container carton) careone ® ndc 72476-500-03 compare to the active ingredient in nexium ® 24 hr see new warning information esomeprazole magnesium delayed-release capsules usp 20 mg* acid reducer 24 hr treats frequent heartburn may take 1 to 4 days for full effect capsules actual size 42 capsules (3 bottles of 14 each) three 14-day courses of treatment package label-principal display panel - 20 mg (42 capsules container carton)