Over-the-counter drug · ANDA
Acid Reducer (omeprazole) NDC 0536-1322
Omeprazole magnesium 20 mg/1 · Tablet, Delayed release · Oral · Rugby Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1322-13 | 00536132213 | 3 BOTTLE in 1 CARTON (0536-1322-13) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 15, 2020 | |
| 0536-1322-71 | 00536132271 | 2 BOTTLE in 1 CARTON (0536-1322-71) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 15, 2020 | |
| 0536-1322-88 | 00536132288 | 1 BOTTLE in 1 CARTON (0536-1322-88) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 15, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Acid Reducer
- Generic name (nonproprietary)
- omeprazole
- Active ingredients
- Omeprazole magnesium — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Rugby Laboratories
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206877
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 0536-1322_6616864c-9739-4e69-86a1-29c07441f9baSPL ID 6616864c-9739-4e69-86a1-29c07441f9baSPL set ID 33990795-e994-4307-a570-9e8e8b44c473RxCUI 402014UNII 426QFE7XLKUPC 0305361322885
- 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
N400536132213followed by a unit qualifier and the quantityPackage 00536-1322-13. 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)
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
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206877
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 |
|---|---|---|---|---|
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | NORTHEAST PHARMA | 80136-852 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | KROGER COMPANY | 30142-077 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | INNOVUS PHARMACEUTICALS, INC. | 57483-120 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Cardinal Health | 70000-0521 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Best Choice | 63941-006 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Bi-Mart | 37835-189 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | DISCOUNT DRUG MART | 53943-016 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Winco Foods, LLC. | 67091-316 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Fred's, Inc. | 55315-996 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | CVS Pharmacy, Inc. | 69842-941 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Family Dollar Stores, LLC | 55319-037 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Aurohealth LLC | 58602-729 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | RELIABLE 1 LABORATORIES LLC | 69618-054 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | 7-Eleven | 10202-722 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Aurohealth LLC | 58602-826 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | WALGREEN CO. | 0363-1008 |
| Amazon Basic Care Omeprazoleomeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Amazon.com Services LLC | 72288-409 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Aurohealth LLC | 58602-850 |
| Acid Reduceromeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Wal-Mart Stores, Inc. | 49035-983 |