Omeprazole
- Product NDC
- 16714-630
- 11-digit product format
- 167140630
- Labeler code
- 16714
- Product ID
- 16714-630_fe36a9a7-13d0-f4f1-1e31-b35cf651b79d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA078490
- Marketing category
- ANDA
- Marketing start
- 2026-03-01
- Substance
- OMEPRAZOLE
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omeprazole
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OMEPRAZOLE | 10 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | KG60484QX9 |
| Rxcui | 198051, 199119, 200329 |
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 |
|---|---|---|---|---|---|---|
| 16714-630-01 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16714-630-01 | EA - Each | 16714-630 | 6081b009-82ab-49d4-9c42-d2b725a7073c | 1 | 2026-04-20 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | PSN | 40a75dc7-49b7-5c9d-6c5f-d4682ec6922e | 6 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 40a75dc7-49b7-5c9d-6c5f-d4682ec6922e | 6 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 40a75dc7-49b7-5c9d-6c5f-d4682ec6922e | 6 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | SCD | 40a75dc7-49b7-5c9d-6c5f-d4682ec6922e | 6 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 40a75dc7-49b7-5c9d-6c5f-d4682ec6922e | 6 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 40a75dc7-49b7-5c9d-6c5f-d4682ec6922e | 6 |
| 199119 | omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule | SY | 40a75dc7-49b7-5c9d-6c5f-d4682ec6922e | 6 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 40a75dc7-49b7-5c9d-6c5f-d4682ec6922e | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 16714-630-01 | 16714063001 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-630-01) | 2026-03-01 | No | No | Current |