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  4. NDC Product Code: 54868-5309 Prilosec Otc

NDC 54868-5309 Prilosec Otc

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-5309?
  5. Prilosec Otc Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
54868-5309
Proprietary Name:
Prilosec Otc
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
6ceb26ec-7ae4-45d5-96d1-82439273613b
Start Marketing Date: [9]
05-23-2005
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328)
Shape:
OVAL (C48345)
Size(s):
15 MM
Imprint(s):
P
Score:
1

Code Structure Chart

Product Details

What is NDC 54868-5309?

The NDC code 54868-5309 is assigned by the FDA to the product Prilosec Otc which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54868-5309-0 3 carton in 1 carton / 1 blister pack in 1 carton / 14 tablet, delayed release in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Prilosec Otc?

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 hours14-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.

Which are Prilosec Otc UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Prilosec Otc Inactive Ingredients UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Prilosec Otc?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 402014 - omeprazole 20 MG Delayed Release Oral Tablet
  • RxCUI: 402014 - omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet
  • RxCUI: 608796 - PriLOSEC OTC 20 MG Delayed Release Oral Tablet
  • RxCUI: 608796 - omeprazole 20 MG Delayed Release Oral Tablet [Prilosec]
  • RxCUI: 608796 - Prilosec 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet

* Please review the disclaimer below.

Product Footnotes

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

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".