Omeprazole
- Product NDC
- 68071-2199
- 11-digit product format
- 680712199
- Labeler code
- 68071
- Product ID
- 68071-2199_1d75df28-a397-f1e7-e063-6294a90a5058
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NuCarePharmaceuticals, Inc.
- Application
- ANDA091672
- Marketing category
- ANDA
- Marketing start
- 2014-10-31
- 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
- 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 table| Ingredient | Strength |
|---|
| OMEPRAZOLE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG60484QX9 |
| Rxcui | 200329 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-2199-4 | 2023-04-24 | C162847 | 48780-1 | ba0f9c33-3a41-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989 |
| 68071-2199-6 | 2023-04-24 | C162847 | 48780-1 | ba0f9c33-3a41-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989 |
| 68071-2199-7 | 2023-04-24 | C162847 | 48780-1 | ba0f9c33-3a41-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989 |
| 68071-2199-9 | 2023-04-24 | C162847 | 48780-1 | ba0f9c33-3a41-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989 |
| 68071-2199-4 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-3a41-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989 |
| 68071-2199-6 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-3a41-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989 |
| 68071-2199-7 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-3a41-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989 |
| 68071-2199-9 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-3a41-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989 |
| 68071-2199-4 | 2021-02-23 | C162847 | 48780-1 | ba0f9c33-3a41-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989 |
| 68071-2199-6 | 2021-02-23 | C162847 | 48780-1 | ba0f9c33-3a41-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989 |
| 68071-2199-7 | 2021-02-23 | C162847 | 48780-1 | ba0f9c33-3a41-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989 |
| 68071-2199-9 | 2021-02-23 | C162847 | 48780-1 | ba0f9c33-3a41-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989 |
| 68071-2199-4 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3a41-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989 |
| 68071-2199-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3a41-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989 |
| 68071-2199-7 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3a41-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989 |
| 68071-2199-9 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3a41-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-2199-4 | Omeprazole | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 6 |
| 68071-2199-6 | Omeprazole | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 6 |
| 68071-2199-7 | Omeprazole | 7 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 7 | | 6 |
| 68071-2199-9 | Omeprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2199 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [NUCAREPHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240719_4be616c4-1b9a-5654-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-2199-4 | 68071219904 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2199-4) | 2017-03-29 | 0000-00-00 | No | No | Current |
| 68071-2199-6 | 68071219906 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2199-6) | 2017-03-29 | 0000-00-00 | No | No | Current |
| 68071-2199-7 | 68071219907 | 7 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2199-7) | 2017-03-29 | 0000-00-00 | No | No | Current |
| 68071-2199-9 | 68071219909 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2199-9) | 2017-03-29 | 0000-00-00 | No | No | Current |