Prescription drug · ANDA
Omeprazole NDC 63187-805
Omeprazole 10 mg/1 · Capsule, Delayed release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-805-60 | 63187080560 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-805-60)Marketed from Jan 2, 2017 | |
| 63187-805-90 | 63187080590 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-805-90)Marketed from Jan 2, 2017 |
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 — 10 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 63187-805_cc7a83fe-a933-4a9a-b6ac-a2b1d85cdeb1SPL ID cc7a83fe-a933-4a9a-b6ac-a2b1d85cdeb1SPL set ID f0f61a89-700d-481d-9255-6f9a9afa7025RxCUI 199119UNII KG60484QX9UPC 0363187805609
- 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
N463187080560followed by a unit qualifier and the quantityPackage 63187-0805-60. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-0332 |
| 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 20 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Limited | 55111-158 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Limited | 55111-159 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Quality Care Products, LLC | 49999-265 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-833 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-1157 |
| Omeprazole DRomeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0071 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 43063-743 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Quallent Pharmaceuticals Health LLC | 82009-022 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0415 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | QPharma, Inc. | 42708-158 |