Prescription drug · ANDA
Omeprazole DR (Omeprazole) NDC 80425-0071
Omeprazole 20 mg/1 · Capsule, Delayed release · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0071-1 | 8042500710180425007101 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0071-1)Marketed from Oct 25, 2019 | |
| 80425-0071-2 | 8042500710280425007102 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0071-2)Marketed from Oct 25, 2019 | |
| 80425-0071-3 | 8042500710380425007103 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0071-3)Marketed from Oct 25, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Omeprazole DRSuffix: DR
- Generic name (nonproprietary)
- omeprazole
- Active ingredients
- Omeprazole — 20 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075576
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0071_2a98f01a-8da1-0770-e063-6294a90a7babSPL ID 2a98f01a-8da1-0770-e063-6294a90a7babSPL set ID af85e324-ef9f-196c-e053-2995a90a384eRxCUI 198051UNII KG60484QX9
- Pharmacologic class
- Proton Pump Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480425007101followed by a unit qualifier and the quantityPackage 80425-0071-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
1. Indications and Usage Section 1 INDICATIONS AND USAGE 1.1 Treatment of Active Duodenal Ulcer Omeprazole delayed-release capsules 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. 1.2 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Triple Therapy Omeprazole delayed-release capsules 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 …
Excerpt only. Read the full label for complete information.
About NDC 80425-0071
- What is NDC 80425-0071?
- 80425-0071 is the product NDC for Omeprazole DR (omeprazole), Omeprazole 20 mg/1 capsule, delayed release, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omeprazole DR (Omeprazole).
- What is the active ingredient?
- Omeprazole.
- Who is the labeler?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Omeprazole DR?
- 3 other product NDCs are listed under this name. See all Omeprazole DR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Omeprazole DR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Omeprazole DRomeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0109 | 80425-0109-01 |
| Omeprazole DRomeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0070 | 80425-0070-0180425-0070-0280425-0070-03+1 more |
| Omeprazole DRomeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0169 | 80425-0169-0180425-0169-0280425-0169-03 |
Other NDCs under ANDA 075576
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | NorthStar Rx LLC | 16714-714 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | QPharma, Inc. | 42708-158 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 43063-743 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Quality Care Products, LLC | 49999-265 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-1157 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Northwind Health Company, LLC | 51655-061 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Limited | 55111-157 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Limited | 55111-159 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-833 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 63187-805 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-0332 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0415 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Quallent Pharmaceuticals Health LLC | 82009-022 |