Omeprazole
Innovus Pharmaceuticals, Inc.
Human Otc Drug
NDC 57483-740Omeprazole is a human otc drug labeled by 'Innovus Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Omeprazole is 57483-740. This drug is available in dosage form of Capsule, Delayed Release. The names of the active, medicinal ingredients in Omeprazole drug includes Omeprazole Magnesium - 20.6 mg/1 . The currest status of Omeprazole drug is Active.
Drug Information:
| Drug NDC: | 57483-740 |
| 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: | Omeprazole |
| 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: | Omeprazole |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Innovus Pharmaceuticals, Inc. |
| 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: | OMEPRAZOLE MAGNESIUM - 20.6 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: | 06 Aug, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 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: | ANDA210593 |
| 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: | INNOVUS PHARMACEUTICALS, INC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198051
|
| 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: | 426QFE7XLK
|
| 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 |
|---|
| 57483-740-42 | 3 BOTTLE in 1 CARTON (57483-740-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57483-740-01) | 06 Aug, 2020 | 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:
Omeprazole omeprazole omeprazole magnesium omeprazole ferrosoferric oxide gelatin, unspecified hydroxypropyl cellulose, unspecified hypromellose 2208 (100 mpa.s) magnesium carbonate magnesium stearate methacrylic acid - ethyl acrylate copolymer (1:1) type a polysorbate 80 potassium hydroxide propylene glycol shellac sodium stearyl fumarate talc titanium dioxide triethyl citrate starch, corn sucrose fd&c blue no. 1 fd&c red no. 40 polyethylene glycol 6000 rg49
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 omeprazole. do not use if you have: â trouble or pain swallowing food, vomiting with blood, or bloody or black stools â heartburn with lightheadedness, sweating or dizziness â chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness â frequent chest pain these may be signs of a serious condition. see your doctor. ask a doctor before use if you have: â had heartburn over 3 months. this may be a sign of a more serious condition. â frequent wheezing, particularly with heartburn â unexplained weight loss â nausea or vomiting â 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: â your heartburn continues or worsens â you need to take this product for more than 14 days â you need t
Read more...o take more than 1 course of treatment every 4 months â you get diarrhea â 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).
Dosage and Administration:
Directions ⪠for adults 18 years of age and older â this product is to be used once a day (every 24 hours), every day for 14 days â it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-day course of treatment â swallow 1 capsule with a glass of water before eating in the morning â take every day for 14 days â do not take more than 1 capsule a day â do not use for more than 14 days unless directed by your doctor â swallow whole. do not chew or crush capsules. repeated 14-day courses (if needed) â you may repeat a 14-day course every 4 months â 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. heartburn in children may sometimes be caused by a serious condition. other information ⪠read the directions and warnings before use â keep the carton. it contains important information. â
Read more... store at 20-25°c (68-77°f). [see usp controlled room temperature]. protect from moisture
Package Label Principal Display Panel:
Package/label principal display panel ndc 57483-740-42 compare to the active ingredient of prilosec otc ® treats frequent heartburn! omepracaredr ⢠omeprazole delayed-release capsules 20 mg* acid reducer mini cap 40% smaller capsule 24hr 42 capsules three 14-day courses of treatment may take 1 to 4 days for full effect spl-innovus-carton
Further Questions:
Questions call toll-free monday to friday 8:30 am to 5 pm est at 1-800-818-4555 .