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  4. NDC Product Code: 61919-773 Omeprazole Dr

NDC 61919-773 Omeprazole Dr

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 61919-773?
  5. Omeprazole Dr Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 61919-773 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
61919-773
Proprietary Name:
Omeprazole Dr
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Direct Rx
Labeler Code:
61919
Product Label ID:
c6bc8fb7-2862-464a-b7c9-e409034f072a
FDA Application Number: [6]
ANDA076048
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
01-01-2015
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328 - OPAQUE)
BROWN (C48332 - REDDISH BROWN)
Shape:
CAPSULE (C48336)
Size(s):
18 MM
21 MM
Imprint(s):
APO;020
APO;040
Score:
1

Code Structure Chart

Product Details

What is NDC 61919-773?

The NDC code 61919-773 is assigned by the FDA to the product Omeprazole Dr which is product labeled by Direct Rx. The product's dosage form is . The product is distributed in a single package with assigned NDC code 61919-773-30 30 capsule, delayed release in 1 bottle . 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 Omeprazole Dr?

1.1 Duodenal Ulcer (adults)Omeprazole delayed-release capsules, USP are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.Omeprazole delayed-release capsules, USP, in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.Omeprazole delayed-release capsules, USP, in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1) and Dosage and Administration (2)].Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted. [See Microbiology section (12.4)], and the clarithromycin package insert, Microbiology section.)1.2 Gastric Ulcer (adults)Omeprazole delayed-release capsules, USP are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults. [See Clinical Studies (14.2)]1.3 Treatment of Gastroesophageal Reflux Disease (GERD) (adults and pediatric patients)Symptomatic GERDOmeprazole delayed-release capsules, USP are indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults.Erosive EsophagitisOmeprazole delayed-release capsules, USP are indicated for the short-term treatment (4 to 8 weeks) of erosive esophagitis that has been diagnosed by endoscopy in pediatric patients and adults. [See Clinical Studies (14.4)]The efficacy of omeprazole delayed-release capsules, USP used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole may be considered.1.4 Maintenance of Healing of Erosive Esophagitis (adults)Omeprazole delayed-release capsules, USP are indicated to maintain healing of erosive esophagitis in pediatric patients and adults.Controlled studies do not extend beyond 12 months. [See Clinical Studies (14.4)]1.5 Pathological Hypersecretory ConditionsOmeprazole delayed-release capsules, USP are indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.

Which are Omeprazole Dr UNII Codes?

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

Which are Omeprazole Dr 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 Omeprazole Dr?

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: 198051 - omeprazole 20 MG Delayed Release Oral Capsule
  • RxCUI: 198051 - omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule
  • RxCUI: 200329 - omeprazole 40 MG Delayed Release Oral Capsule

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Patient Education

Omeprazole


Prescription omeprazole is used alone or with other medications to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription omeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription omeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults and children 1 year of age and older with GERD. Prescription omeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Prescription omeprazole is also used to treat ulcers (sores in the lining of the stomach or intestine) and it is also used with other medications to treat and prevent the return of ulcers caused by a certain type of bacteria (H. pylori) in adults. Nonprescription (over-the-counter) omeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Omeprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.
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* 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.

[6] 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.

[8] 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.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".