Prescription drug · ANDA
Omeprazole NDC 71335-1395
Omeprazole 40 mg/1 · Capsule, Delayed release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1395-1 | 71335139501 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-1)Marketed from Feb 1, 2012 | |
| 71335-1395-2 | 71335139502 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-2)Marketed from Feb 1, 2012 | |
| 71335-1395-3 | 71335139503 | 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-3)Marketed from Feb 1, 2012 | |
| 71335-1395-4 | 71335139504 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-4)Marketed from Feb 1, 2012 | |
| 71335-1395-5 | 71335139505 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-5)Marketed from Feb 1, 2012 | |
| 71335-1395-6 | 71335139506 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-6)Marketed from Feb 1, 2012 | |
| 71335-1395-7 | 71335139507 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-7)Marketed from Feb 1, 2012 | |
| 71335-1395-8 | 71335139508 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-8)Marketed from Feb 1, 2012 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 40 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076048
- Marketing start
- Marketing end
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-1395_f5868802-1b1f-4d48-8793-39d25a65b0d8SPL ID f5868802-1b1f-4d48-8793-39d25a65b0d8SPL set ID 44349466-73ea-4053-8ff6-5b4b7372c9cdRxCUI 198051, 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
N471335139501followed by a unit qualifier and the quantityPackage 71335-1395-01. 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 is 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 1 year of age and older ( 1.4 ) Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older ( 1.5 ) Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older ( 1.6 ) Pathologic hypersecretory conditions in adults ( 1.7 ) 1.1 Treatment of Active Duodenal Ulcer Omeprazole del…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076048
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 40 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 63187-170 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Apotex Corp | 60505-3952 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-0569 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-248 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Apotex Corp | 60505-0065 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-1636 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 63187-061 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Apotex Corp | 60505-0145 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Apotex Corp | 60505-0146 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 63187-070 |