NDC 51660-029 Omeprazole

Omeprazole

NDC Product Code 51660-029

NDC Code: 51660-029

Proprietary Name: Omeprazole 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: Omeprazole 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):
BROWN (C48332 - BROWNISH PINK)
Shape: OVAL (C48345)
Size(s):
12 MM
Imprint(s):
20
Score: 1

NDC Code Structure

  • 51660 - Ohm Laboratories Inc.
    • 51660-029 - Omeprazole

NDC 51660-029-14

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

NDC 51660-029-44

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

NDC Product Information

Omeprazole with NDC 51660-029 is a a human over the counter drug product labeled by Ohm Laboratories Inc.. The generic name of Omeprazole is omeprazole. The product's dosage form is tablet, delayed release and is administered via oral form.

Labeler Name: Ohm Laboratories Inc.

Dosage Form: Tablet, Delayed Release - A solid dosage form 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.

Omeprazole 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.

  • OMEPRAZOLE 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.

  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S) (UNII: 36BGF0E889)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MONOETHANOLAMINE (UNII: 5KV86114PT)
  • METHYLCELLULOSE (1500 MPA.S) (UNII: P0NTE48364)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • SODIUM STEARATE (UNII: QU7E2XA9TG)
  • SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • AMMONIA (UNII: 5138Q19F1X)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
  • SHELLAC (UNII: 46N107B71O)

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: Ohm Laboratories Inc.
Labeler Code: 51660
FDA Application Number: ANDA207891 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: 06-01-2019 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.

Omeprazole 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

Other

Drug Facts

Distributed by:Ohm Laboratories Inc.New Brunswick, NJ 08901Manufactured by:Sun Pharmaceutical Industries LimitedSurvey No. 259/15, Dadra-396 191,(U.T. of D & NH), India.

Active Ingredient(In Each Tablet)

Omeprazole USP 20 mg

Purpose

Acid reducer

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

Allergy Alert

Do not use if you are allergic to omeprazole.

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

Otc - Ask Doctor/Pharmacist

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 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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

  • For adults 18 years of age and olderthis product is to be used once a day (every 24 hours), every day for 14 daysit may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatmentswallow 1 tablet with a glass of water before eating in the morningtake every day for 14 daysdo not take more than 1 tablet a daydo not use for more than 14 days unless directed by your doctorswallow whole. Do not chew or crush tablets.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 doctorchildren 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 usekeep the carton. It contains important information.store at 20 to 25° C (68 to 77° F) and protect from moisture

Inactive Ingredients

Anhydrous lactose, hyperomellose, hyperomellose acetate succinate, iron oxide red, iron oxide yellow, lactose monohydrate, methyl cellulose, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, triethyl citrate and titanium dioxide.The imprinting ink contains ammonium hydroxide, black iron oxide, n-butyl alcohol, propylene glycol and shellac.

* Please review the disclaimer below.

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