Omeprazole
- Product NDC
- 0781-2868
- 11-digit product format
- 007812868
- Labeler code
- 0781
- Product ID
- 0781-2868_b182f298-e28f-434b-b6f1-ecfac29d495e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA075757
- Marketing category
- ANDA
- Marketing start
- 2019-07-01
- Substance
- OMEPRAZOLE
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | KG60484QX9 |
| Rxcui | 198051, 199119 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 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 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 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 |
|---|---|---|---|---|---|---|
| 0781-2868-01 | Omeprazole | 100 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 100 | 9 | |
| 0781-2868-10 | Omeprazole | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | 9 | |
| 0781-2868-31 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 9 | |
| 0781-2868-92 | Omeprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | 9 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 17664f71-154a-47c6-b83c-b349bbc8a98f | 104 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 17664f71-154a-47c6-b83c-b349bbc8a98f | 104 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 17664f71-154a-47c6-b83c-b349bbc8a98f | 104 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | PSN | 516170d4-4913-4577-a2d2-f5c52d1e79c6 | 9 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 516170d4-4913-4577-a2d2-f5c52d1e79c6 | 9 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | SCD | 516170d4-4913-4577-a2d2-f5c52d1e79c6 | 9 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 516170d4-4913-4577-a2d2-f5c52d1e79c6 | 9 |
| 199119 | omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule | SY | 516170d4-4913-4577-a2d2-f5c52d1e79c6 | 9 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 516170d4-4913-4577-a2d2-f5c52d1e79c6 | 9 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | db9f071b-85f4-061f-e053-2995a90a3ff5 | 8 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | db9f071b-85f4-061f-e053-2995a90a3ff5 | 8 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | db9f071b-85f4-061f-e053-2995a90a3ff5 | 8 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | f6f6ad19-ff6a-7cd3-e053-6294a90ae1bf | 4 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | f6f6ad19-ff6a-7cd3-e053-6294a90ae1bf | 4 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | f6f6ad19-ff6a-7cd3-e053-6294a90ae1bf | 4 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | f76c23d5-26b6-cfb2-e053-6294a90aea42 | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | f76c23d5-26b6-cfb2-e053-6294a90aea42 | 3 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | f76c23d5-26b6-cfb2-e053-6294a90aea42 | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | da481f9e-dfa8-3682-e053-2a95a90a333c | 2 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | da481f9e-dfa8-3682-e053-2a95a90a333c | 2 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | da481f9e-dfa8-3682-e053-2a95a90a333c | 2 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 0fb314cb-6291-422c-98ff-24d8449992f6 | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 0fb314cb-6291-422c-98ff-24d8449992f6 | 1 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 0fb314cb-6291-422c-98ff-24d8449992f6 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0781-2868-01 | 00781286801 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2868-01) | 2019-08-01 | 0000-00-00 | No | No | Current |
| 0781-2868-10 | 00781286810 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2868-10) | 2019-07-01 | 0000-00-00 | No | No | Current |
| 0781-2868-31 | 00781286831 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2868-31) | 2019-07-01 | 0000-00-00 | No | No | Current |
| 0781-2868-92 | 00781286892 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2868-92) | 2019-07-01 | 0000-00-00 | No | No | Current |