Prescription drug · ANDA
Omeprazole NDC 70700-149
Omeprazole 10 mg/1 · Capsule, Delayed release · Oral · Xiromed, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-149-01 | 70700014901 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70700-149-01)Marketed from Jan 8, 2021 | |
| 70700-149-05 | 70700014905 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70700-149-05)Marketed from Feb 20, 2019 | |
| 70700-149-30 | 70700014930 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70700-149-30)Marketed from Feb 20, 2019 |
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
- Xiromed, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212977
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 70700-149_49528611-b139-6768-e43e-bc6f26715fa3SPL ID 49528611-b139-6768-e43e-bc6f26715fa3SPL set ID 38bd8e13-591e-f11b-7d8a-11717c56493cRxCUI 198051, 199119, 200329UNII KG60484QX9UPC 0370700150016, 0370700149300
- 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
N470700014901followed by a unit qualifier and the quantityPackage 70700-0149-01. 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.
Other NDCs under ANDA 212977
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 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 83209-150 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-5902 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-5901 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 71205-613 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-641 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-3278 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-287 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Xiromed, LLC | 70700-150 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Xiromed, LLC | 70700-151 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-880 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8406 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-813 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-663 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 71205-907 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-963 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-943 |