Prescription drug · ANDA
Omeprazole NDC 0781-2790
Omeprazole 20 mg/1 · Capsule, Delayed release · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-2790-01 | 0078127900100781279001 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2790-01)Marketed from Jan 28, 2003 | |
| 0781-2790-10 | 0078127901000781279010 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2790-10)Marketed from Jan 28, 2003 | |
| 0781-2790-31 | 0078127903100781279031 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2790-31)Marketed from Jan 28, 2003 | |
| 0781-2790-92 | 0078127909200781279092 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2790-92)Marketed from Jan 28, 2003 |
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)
- Omeprazole
- Generic name (nonproprietary)
- omeprazole
- Active ingredients
- Omeprazole — 20 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075757
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 0781-2790_24a57c2e-eda8-4c3f-9c81-a28a5b9a9229SPL ID 24a57c2e-eda8-4c3f-9c81-a28a5b9a9229SPL set ID e4562da8-9d94-4417-9f80-c1ffd4247259RxCUI 198051, 199119UNII 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
N400781279001followed by a unit qualifier and the quantityPackage 00781-2790-01. 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)
Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: • Treatment of active duodenal ulcer in adults ( 1.1 ) • Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) • Treatment of active benign gastric ulcer in adults ( 1.3 ) • Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4 ) • Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5 ) • Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6 ) • Pathologic hypersecretory conditions in adults ( 1.7 ) 1.1 Treatme…
Excerpt only. Read the full label for complete information.
About NDC 0781-2790
- What is NDC 0781-2790?
- 0781-2790 is the product NDC for Omeprazole, Omeprazole 20 mg/1 capsule, delayed release, listed with the FDA by Sandoz Inc. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omeprazole.
- What is the active ingredient?
- Omeprazole.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. 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?
- 252 other product NDCs are listed under this name. See all Omeprazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Omeprazole 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 | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Chain Drug Marketing Association, Inc. | 83324-309 | 83324-0309-1483324-0309-42 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Amazon.com Services LLC | 72288-666 | 72288-0666-5572288-0666-74 |
| Omeprazoleomeprazole magnesium | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | YYBA CORP | 73581-015 | 73581-0015-03 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Discount Drug Mart, Inc | 53943-038 | 53943-0038-1453943-0038-42 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Amazon.com Services LLC | 72288-934 | 72288-0934-01 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | H E B | 59640-699 | 59640-0699-0159640-0699-03 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Unit Dose Solutions, Inc. | 87441-063 | 87441-0063-01 |
| Omeprazole | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Safeway | 21130-783 | 21130-0783-0121130-0783-03 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Preferred Phharmaceuticals Inc. | 68788-4104 | 68788-4104-0168788-4104-0268788-4104-03+4 more |
| omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Amazon.com Services LLC | 72288-606 | 72288-0606-03 |
Other NDCs under ANDA 075757
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 | St. Mary's Medical Park Pharmacy | 60760-868 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 82804-166 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | QPharma Inc | 42708-170 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Sandoz Inc | 0781-2785 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-9609 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Sandoz Inc | 0781-2859 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Sandoz Inc | 0781-2868 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Northwind Health Company, LLC | 51655-893 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8864 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Chartwell RX, LLC | 62135-559 |