Prilosec
- Product NDC
- 70515-610
- 11-digit product format
- 705150610
- Labeler code
- 70515
- Product ID
- 70515-610_296db0e8-af6e-4053-874d-2a7c8f7aba50
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole magnesium
- Dosage form
- GRANULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Covis Pharma US, Inc
- Application
- NDA022056
- Marketing category
- NDA
- Marketing start
- 2017-08-25
- Substance
- OMEPRAZOLE MAGNESIUM
- Active strength
- 10 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Prilosec
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OMEPRAZOLE MAGNESIUM | 10 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 426QFE7XLK |
| Rxcui | 797058, 797061, 797063, 797065 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 873ef493-6b37-49d8-ac7f-bfca4117d2c1 | Product name | 5 | 20210607 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| f33561b9-47cb-411c-a228-16c62e346cd4 | Product name | 1 | 20200415 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70515-610-01 | Prilosec | 30 in 1 CARTON | GRANULE, DELAYED RELEASE | 30 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70515-610-01 | EA - Each | 70515-610 | 46c2260e-143b-4eb9-993e-b7cc40e82068 | 1 | 2017-10-13 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 797058 | omeprazole 10 MG Delayed Release Granules for Oral Suspension | PSN | b6761f84-53ac-4745-a8c8-1e5427d7e179 | 8 |
| 797063 | omeprazole 2.5 MG Delayed Release Granules for Oral Suspension | PSN | b6761f84-53ac-4745-a8c8-1e5427d7e179 | 8 |
| 797061 | PriLOSEC 10 MG Delayed Release Granules for Oral Suspension | PSN | b6761f84-53ac-4745-a8c8-1e5427d7e179 | 8 |
| 797065 | PriLOSEC 2.5 MG Delayed Release Granules for Oral Suspension | PSN | b6761f84-53ac-4745-a8c8-1e5427d7e179 | 8 |
| 797061 | omeprazole 10 MG Granules for Oral Suspension [Prilosec] | SBD | b6761f84-53ac-4745-a8c8-1e5427d7e179 | 8 |
| 797065 | omeprazole 2.5 MG Granules for Oral Suspension [Prilosec] | SBD | b6761f84-53ac-4745-a8c8-1e5427d7e179 | 8 |
| 797058 | omeprazole 10 MG Granules for Oral Suspension | SCD | b6761f84-53ac-4745-a8c8-1e5427d7e179 | 8 |
| 797063 | omeprazole 2.5 MG Granules for Oral Suspension | SCD | b6761f84-53ac-4745-a8c8-1e5427d7e179 | 8 |
| 797058 | omeprazole 10 MG (as omeprazole magnesium 11.2 MG) Delayed Release Granules for Oral Suspension | SY | b6761f84-53ac-4745-a8c8-1e5427d7e179 | 8 |
| 797058 | omeprazole 10 MG Delayed Release Granules for Oral Suspension | SY | b6761f84-53ac-4745-a8c8-1e5427d7e179 | 8 |
| 797063 | omeprazole 2.5 MG (as omeprazole magnesium 2.8 MG) Delayed Release Granules for Oral Suspension | SY | b6761f84-53ac-4745-a8c8-1e5427d7e179 | 8 |
| 797063 | omeprazole 2.5 MG Delayed Release Granules for Oral Suspension | SY | b6761f84-53ac-4745-a8c8-1e5427d7e179 | 8 |
| 797061 | Prilosec 10 MG (omeprazole magnesium 11.2 MG) Delayed Release Granules for Oral Suspension | SY | b6761f84-53ac-4745-a8c8-1e5427d7e179 | 8 |
| 797061 | Prilosec 10 MG Delayed Release Granules for Oral Suspension | SY | b6761f84-53ac-4745-a8c8-1e5427d7e179 | 8 |
| 797065 | Prilosec 2.5 MG (omeprazole magnesium 2.8 MG) Delayed Release Granules for Oral Suspension | SY | b6761f84-53ac-4745-a8c8-1e5427d7e179 | 8 |
| 797065 | Prilosec 2.5 MG Delayed Release Granules for Oral Suspension | SY | b6761f84-53ac-4745-a8c8-1e5427d7e179 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70515-610-01 | 70515061001 | 30 GRANULE, DELAYED RELEASE in 1 CARTON (70515-610-01) | 2017-08-25 | 0000-00-00 | No | No | Current |