NDC 69238-1050 Esomeprazole Magnesium

Esomeprazole Magnesium

NDC Product Code 69238-1050

NDC Code: 69238-1050

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):
WHITE (C48325)
Shape: CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
AMNEAL1050
Score: 1

NDC Code Structure

  • 69238 - Amneal Pharmaceuticals Ny Llc
    • 69238-1050 - Esomeprazole Magnesium

NDC 69238-1050-1

Package Description: 1 BOTTLE in 1 BLISTER PACK > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4)

NDC 69238-1050-2

Package Description: 2 BOTTLE in 1 CARTON > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4)

NDC 69238-1050-3

Package Description: 3 BOTTLE in 1 CARTON > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4)

NDC 69238-1050-5

Package Description: 1 BOTTLE in 1 CARTON > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4)

NDC 69238-1050-8

Package Description: 3 BOTTLE in 1 BLISTER PACK > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4)

NDC 69238-1050-9

Package Description: 2 BOTTLE in 1 BLISTER PACK > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4)

NDC Product Information

Esomeprazole Magnesium with NDC 69238-1050 is a a human over the counter drug product labeled by Amneal Pharmaceuticals Ny Llc. 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: Amneal Pharmaceuticals Ny Llc

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • AMMONIA (UNII: 5138Q19F1X)
  • BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
  • CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • GELATIN (UNII: 2G86QN327L)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SHELLAC (UNII: 46N107B71O)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SUCROSE (UNII: C151H8M554)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • WATER (UNII: 059QF0KO0R)

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: Amneal Pharmaceuticals Ny Llc
Labeler Code: 69238
FDA Application Number: ANDA209716 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: 06-05-2019 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 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

Drug Facts

Active ingredient(in each capsule)PurposeEsomeprazole 20 mgAcid reducer(*Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)

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

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 stoolsheartburn with lightheadedness, sweating or dizzinesschest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadednessfrequent 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 heartburnunexplained weight lossnausea or vomitingstomach pain

Stop Use And Ask A 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 diarrheayou develop a rash or joint pain

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of The 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 effect14-Day Course of Treatmentswallow 1 capsule with a glass of water before eating in the morningtake every day for 14 daysdo 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 doctorRepeated 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 doctorchildren 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 usekeep the carton. It contains important information.store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

Gelatin, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion type C, mono-and di-glycerides, polysorbate 80, sugar sphere (contains- sucrose, corn starch and purified water), sodium lauryl sulphate, talc, triethyl citrate and titanium dioxide.Each capsule is imprinted with blue pharmaceutical ink which contains butyl alcohol, dehydrated alcohol, FD & C Blue # 2 aluminum lake, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and having one circular line which contains FD & C Blue No. 2 aluminum lake, gelatin and polysorbate 80.

* Please review the disclaimer below.

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