Omeprazole
- Product NDC
- 68071-3007
- 11-digit product format
- 680713007
- Labeler code
- 68071
- Product ID
- 68071-3007_1d788069-c6f1-5785-e063-6394a90afd1b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA091672
- Marketing category
- ANDA
- Marketing start
- 2014-10-31
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omeprazole
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OMEPRAZOLE | 20 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | KG60484QX9 |
| Rxcui | 198051 |
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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-3007-2 | Omeprazole | 28 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 28 | 7 | |
| 68071-3007-3 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 7 | |
| 68071-3007-4 | Omeprazole | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | 7 | |
| 68071-3007-6 | Omeprazole | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | 7 | |
| 68071-3007-8 | Omeprazole | 180 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 180 | 7 | |
| 68071-3007-9 | Omeprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-3007 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.] | 7 | Current NDC, Legacy NDC, 6 package rows | 20240719_6fa6afcf-33b3-3115-e053-2a91aa0abd0b.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 6fa6afcf-33b3-3115-e053-2a91aa0abd0b | 7 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 6fa6afcf-33b3-3115-e053-2a91aa0abd0b | 7 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 6fa6afcf-33b3-3115-e053-2a91aa0abd0b | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-3007-2 | 68071300702 | 28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3007-2) | 2018-06-27 | 0000-00-00 | No | No | Current |
| 68071-3007-3 | 68071300703 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3007-3) | 2018-06-27 | 0000-00-00 | No | No | Current |
| 68071-3007-4 | 68071300704 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3007-4) | 2018-06-27 | 0000-00-00 | No | No | Current |
| 68071-3007-6 | 68071300706 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3007-6) | 2018-06-27 | 0000-00-00 | No | No | Current |
| 68071-3007-8 | 68071300708 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3007-8) | 2018-06-27 | 0000-00-00 | No | No | Current |
| 68071-3007-9 | 68071300709 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3007-9) | 2018-06-27 | 0000-00-00 | No | No | Current |