Prescription drug · ANDA
Omeprazole NDC 65841-760
Omeprazole 20 mg/1 · Capsule, Delayed release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-760-01 | 65841076001 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-760-01)Marketed from Nov 23, 2012 | |
| 65841-760-05 | 65841076005 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-760-05)Marketed from Nov 23, 2012 | |
| 65841-760-06 | 65841076006 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-760-06)Marketed from Nov 23, 2012 | |
| 65841-760-10 | 65841076010 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-760-10)Marketed from Nov 23, 2012 | |
| 65841-760-16 | 65841076016 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-760-16)Marketed from Nov 23, 2012 |
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
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091352
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 65841-760_691b64ae-e6ff-4a10-9973-886901529db0SPL ID 691b64ae-e6ff-4a10-9973-886901529db0SPL set ID 2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2RxCUI 198051, 199119, 200329UNII 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
N465841076001followed by a unit qualifier and the quantityPackage 65841-0760-01. 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 .
Other NDCs under ANDA 091352
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 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7018 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7019 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7021 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Major Pharmaceuticals | 0904-6917 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Zydus Lifesciences Limited | 65841-759 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Zydus Lifesciences Limited | 65841-761 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Cardinal Health 107, LLC | 55154-2332 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-9744 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-411 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-412 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-500 |