NDC 21130-714 Signature Care Esomeprazole Magnesium

Esomeprazole

NDC Product Code 21130-714

NDC CODE: 21130-714

Proprietary Name: Signature Care 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 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)
Shape: CAPSULE (C48336)
Size(s):
11 MM
Imprint(s):
7U4
Score: 1

NDC Code Structure

NDC 21130-714-01

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

NDC 21130-714-03

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

NDC Product Information

Signature Care Esomeprazole Magnesium with NDC 21130-714 is a a human over the counter drug product labeled by Safeway. The generic name of Signature Care Esomeprazole Magnesium is esomeprazole. The product's dosage form is capsule, delayed release and is administered via oral form.

Labeler Name: Safeway

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.

Signature Care 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 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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MEGLUMINE (UNII: 6HG8UB2MUY)
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SHELLAC (UNII: 46N107B71O)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

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.
  • 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: Safeway
Labeler Code: 21130
FDA Application Number: ANDA207193 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: 07-02-2020 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: 12-31-2021 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.

Signature Care Esomeprazole Magnesium Product Label Images

Signature Care 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 (In Each Capsule)

Esomeprazole 20 mg(Each delayed-release capsule corresponds to 22 mg esomeprazole magnesium dihydrate)

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 dizziness •chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness •frequent chest painThese 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 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 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)

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 effect14-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 doctorRepeated 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)

Inactive Ingredients

FD&C blue no. 1, FD&C blue no. 1 aluminum lake, FD&C red no. 3, ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, shellac, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

* Please review the disclaimer below.