OMEPRAZOLE
- Product NDC
- 51991-644
- 11-digit product format
- 519910644
- Labeler code
- 51991
- Product ID
- 51991-644_304153b1-8616-40d5-ac5f-a47764b034c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OMEPRAZOLE
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA203481
- Marketing category
- ANDA
- Marketing start
- 2017-07-03
- Marketing end
- 2022-03-31
- 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
- 0000-00-00
- 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 |
|---|---|---|---|---|---|
| 51991-644-05 | EA - Each | 51991-644 | d4828399-97f4-49aa-897f-35d3f787cc5c | 1 | 2017-11-06 |
| 51991-644-33 | EA - Each | 51991-644 | fc7b30cc-c723-493a-ad97-f52eb72d00e0 | 1 | 2017-11-06 |
| 51991-644-90 | EA - Each | 51991-644 | fbbe8b3c-7b51-4a09-bdf0-dbfc0c12a161 | 1 | 2017-11-06 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | b427aff0-e1ba-4b03-b469-a2e9d9d5f843 | 1 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | b427aff0-e1ba-4b03-b469-a2e9d9d5f843 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51991-644-05 | 51991064405 | 500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-644-05) | 2017-07-03 | 2022-03-31 | No | No | Current |