Omeprazole
- Product NDC
- 51407-303
- 11-digit product format
- 514070303
- Labeler code
- 51407
- Product ID
- 51407-303_de22b48e-7842-5718-e053-2a95a90a0baa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA075410
- Marketing category
- ANDA
- Marketing start
- 2009-01-23
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51407-303-01 | EA - Each | 51407-303 | 1705f7c7-a906-4bd4-b5be-9cd4f2f0fea6 | 1 | 2020-03-10 |
| 51407-303-10 | EA - Each | 51407-303 | 9fc1699c-bcba-49e8-bb84-f7e0b812e1c5 | 1 | 2020-03-10 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 767a7c15-aa5d-4f49-b337-f507f534746f | 3 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 767a7c15-aa5d-4f49-b337-f507f534746f | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 767a7c15-aa5d-4f49-b337-f507f534746f | 3 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 767a7c15-aa5d-4f49-b337-f507f534746f | 3 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 767a7c15-aa5d-4f49-b337-f507f534746f | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51407-303-00 | 51407030300 | 52500 CAPSULE, DELAYED RELEASE in 1 DRUM (51407-303-00) | 2020-02-20 | 0000-00-00 | No | No | Current |
| 51407-303-01 | 51407030301 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51407-303-01) | 2020-02-20 | 0000-00-00 | No | No | Current |
| 51407-303-10 | 51407030310 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51407-303-10) | 2020-02-20 | 0000-00-00 | No | No | Current |