NDC 30142-261 Esomeprazole Magnesium

Esomeprazole Magnesium

NDC Product Code 30142-261

NDC Code: 30142-261

Proprietary Name: Esomeprazole Magnesium What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Esomeprazole Magnesium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Product Characteristics
Color(s):
BLUE (C48333 - LIGHT BLUE CAP)
BLUE (C48333 - DARK BLUE BODY)
Shape: CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
RDY;327
Score: 1

Code Structure
  • 30142 - The Kroger Co.
    • 30142-261 - Esomeprazole Magnesium

NDC 30142-261-14

Package Description: 1 BOTTLE in 1 CARTON > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

NDC 30142-261-28

Package Description: 2 BOTTLE in 1 CARTON > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

NDC 30142-261-42

Package Description: 3 BOTTLE in 1 CARTON > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

NDC Product Information

Esomeprazole Magnesium with NDC 30142-261 is a a human over the counter drug product labeled by The Kroger Co.. The generic name of Esomeprazole Magnesium is esomeprazole magnesium. The product's dosage form is capsule, delayed release and is administered via oral form.

Labeler Name: The Kroger Co.

Dosage Form: Capsule, Delayed Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Esomeprazole Magnesium Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ESOMEPRAZOLE MAGNESIUM 20 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)
  • DIBUTYL SEBACATE (UNII: 4W5IH7FLNY)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
  • POLOXAMER 188 (UNII: LQA7B6G8JG)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POVIDONE K30 (UNII: U725QWY32X)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • SHELLAC (UNII: 46N107B71O)
  • SUCROSE (UNII: C151H8M554)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: The Kroger Co.
Labeler Code: 30142
FDA Application Number: ANDA207673 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 03-15-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Esomeprazole Magnesium Product Label Images

Esomeprazole Magnesium Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient(S) In Each Capsule

*Esomeprazole 20 mg(Each delayed-release capsule corresponds to 20.7 mg esomeprazole magnesium, USP)

Purpose

Acid reducer

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

Allergy alert: Do not use if you are allergic to esomeprazole

Do Not Use If You Have:

  • Trouble or pain swallowing food, vomiting with blood, or bloody or black stools heartburn with lightheadedness, sweating or dizzinesschest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadness frequent chest pain.These may be signs of a serious condition. See your doctor.

Ask A Doctor Before Use If You Have

  • Had heartburn over 3 months. This may be a sign of a more serious condition.frequent wheezing,  particularly with heartburnunexplained weight lossnausea or vomitingstomach pain

Ask A Doctor Or Pharmacist Before Use If You Are Taking

  • Warfarin, clopidogrel or cilostazol (blood-thinning medicines)prescription ant fungal or anti-yeast medicinesdigoxin (heart medicine)diazepam (anxiety medicine)tacrolimus or mycophenolate mofetil (immune system medicine) prescription antiretrovirals (medicines for HIV infection)methotrexate (arthritis medicine)

Stop Use And Ask Doctor If

  • Your heartburn continues or worsensyou need to take this product for more than 14 daysyou need to take more than 1 course of treatment every 4 monthsyou get diarrhea  you develop a rash or joint painIf 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.

Directions

  • Adults 18 years of age and olderthis product is to be used once a day (every 24 hours), every day for 14 daysmay take 1 to 4 days for full effect 14-Day Course of Treatmentswallow 1 capsule with a glass of water before eating in the morningtake every day for 14 days do not take more than 1 capsule a dayswallow 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 monthsdo 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

  • Each capsule contains: magnesium, 15 mgread directions and warnings before usekeep the carton. It contains important informationstore at 20 to 25°C (68 to 77°F)

Inactive Ingredients

Acetyl tributyl citrate, dibutyl sebacate, FD&C Blue #1,  ferroso ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, poloxamer, polysorbate 80, povidone, potassium hydroxide, propylene glycol, shellac, sugar, talc, titanium dioxide

* Please review the disclaimer below.

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