Omeprazole
- Product NDC
- 53002-1104
- 11-digit product format
- 530021104
- Labeler code
- 53002
- Product ID
- 53002-1104_a2741e96-34d0-4b22-a758-377e21ed812b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA075576
- Marketing category
- ANDA
- Marketing start
- 2009-01-21
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-1104-0 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-17d4-f424-e053-dadaa90a57ce | 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 |
| 53002-1104-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-17d4-f424-e053-dadaa90a57ce | 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 |
| 53002-1104-6 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-17d4-f424-e053-dadaa90a57ce | 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 |
| 53002-1104-9 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-17d4-f424-e053-dadaa90a57ce | 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 |
| 53002-1104-0 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-17d4-f424-e053-dadaa90a57ce | 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 |
| 53002-1104-3 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-17d4-f424-e053-dadaa90a57ce | 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 |
| 53002-1104-6 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-17d4-f424-e053-dadaa90a57ce | 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 |
| 53002-1104-9 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-17d4-f424-e053-dadaa90a57ce | 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 |
| 53002-1104-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-17d4-f424-e053-dadaa90a57ce | 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 |
| 53002-1104-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-17d4-f424-e053-dadaa90a57ce | 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 |
| 53002-1104-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-17d4-f424-e053-dadaa90a57ce | 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 |
| 53002-1104-9 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-17d4-f424-e053-dadaa90a57ce | 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 |
|---|
| 53002-1104-0 | Omeprazole | 100 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 100 | | 3 |
| 53002-1104-3 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 3 |
| 53002-1104-6 | Omeprazole | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 3 |
| 53002-1104-9 | Omeprazole | 15 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 15 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1104 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 4 package rows | 20201217_4438a8ee-dfc3-42ae-8057-f5992606891f.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 |
|---|
| 53002-1104-0 | 53002110400 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (53002-1104-0) | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1104-3 | 53002110403 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (53002-1104-3) | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1104-6 | 53002110406 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (53002-1104-6) | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1104-9 | 53002110409 | 15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (53002-1104-9) | 2017-09-01 | 0000-00-00 | No | No | Current |