Over-the-counter drug · ANDA
Omeprazole NDC 69168-476
Omeprazole 20 mg/1 · Tablet, Delayed release · Oral · Allegiant Health
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69168-476-14 | 69168047614 | 1 BOTTLE in 1 CARTON (69168-476-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 21, 2025 | |
| 69168-476-15 | 69168047615 | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (69168-476-15)Marketed from Mar 21, 2025 | |
| 69168-476-42 | 69168047642 | 3 BOTTLE in 1 CARTON (69168-476-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 21, 2025 | |
| 69168-476-61 | 69168047661 | 1 BOTTLE in 1 CARTON (69168-476-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 21, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Omeprazole
- Generic name (nonproprietary)
- omeprazole
- Active ingredients
- Omeprazole — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Allegiant Health
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211732
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 69168-476_37309c28-8650-401e-9a39-6b52112e0bafSPL ID 37309c28-8650-401e-9a39-6b52112e0bafSPL set ID 3344c589-c4ac-4f2d-8d32-828db4e825a6RxCUI 402014UNII KG60484QX9UPC 0369168476141
- 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
N469168047614followed by a unit qualifier and the quantityPackage 69168-0476-14. 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(s) • 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 211732
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 |
|---|---|---|---|---|
| GoodMeds 24HR Acid Reducer Omeprazole 20mgomeprazole 20mg | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Cabinet Health P.B.C. | 82725-4052 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-011 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-6888 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Camber Consumer Care Inc | 69230-318 |