Esomeprazole Magnesium
- Product NDC
- 71335-0807
- 11-digit product format
- 713350807
- Labeler code
- 71335
- Product ID
- 71335-0807_e6e99a77-7dd9-4fd5-a91a-cb09a573bd58
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205606
- Marketing category
- ANDA
- Marketing start
- 2016-04-21
- Substance
- ESOMEPRAZOLE MAGNESIUM DIHYDRATE
- 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
- Esomeprazole Magnesium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESOMEPRAZOLE MAGNESIUM DIHYDRATE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 36H71644EQ |
| Rxcui | 606726 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 71335-0807-1 | 2024-05-22 | C162847 | 48780-1 | 1030e365-5b2c-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) |
| 71335-0807-2 | 2024-05-22 | C162847 | 48780-1 | 1030e365-5b2c-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) |
| 71335-0807-3 | 2024-05-22 | C162847 | 48780-1 | 1030e365-5b2c-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) |
| 71335-0807-4 | 2024-05-22 | C162847 | 48780-1 | 1030e365-5b2c-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) |
| 71335-0807-5 | 2024-05-22 | C162847 | 48780-1 | 1030e365-5b2c-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) |
| 71335-0807-6 | 2024-05-22 | C162847 | 48780-1 | 1030e365-5b2c-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) |
| 71335-0807-7 | 2024-05-22 | C162847 | 48780-1 | 1030e365-5b2c-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) |
| 71335-0807-8 | 2024-05-22 | C162847 | 48780-1 | 1030e365-5b2c-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) |
| 71335-0807-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5b2c-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) |
| 71335-0807-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5b2c-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) |
| 71335-0807-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5b2c-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) |
| 71335-0807-4 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5b2c-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) |
| 71335-0807-5 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5b2c-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) |
| 71335-0807-6 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5b2c-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) |
| 71335-0807-7 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5b2c-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) |
| 71335-0807-8 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5b2c-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-0807-1 | Esomeprazole Magnesium | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 13 |
| 71335-0807-2 | Esomeprazole Magnesium | 10 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 10 | | 13 |
| 71335-0807-3 | Esomeprazole Magnesium | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 13 |
| 71335-0807-4 | Esomeprazole Magnesium | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 13 |
| 71335-0807-5 | Esomeprazole Magnesium | 42 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 42 | | 13 |
| 71335-0807-6 | Esomeprazole Magnesium | 120 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 120 | | 13 |
| 71335-0807-7 | Esomeprazole Magnesium | 180 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 180 | | 13 |
| 71335-0807-8 | Esomeprazole Magnesium | 20 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 20 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0807 | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK] | 13 | Current NDC, Legacy NDC, 8 package rows | 20240724_009794ae-8199-4176-9dc6-4c5e752d845c.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 |
|---|
| 71335-0807-1 | 71335080701 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0807-1) | 2018-06-19 | 0000-00-00 | No | No | Current |
| 71335-0807-2 | 71335080702 | 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0807-2) | 2018-05-29 | 0000-00-00 | No | No | Current |
| 71335-0807-3 | 71335080703 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0807-3) | 2018-07-11 | 0000-00-00 | No | No | Current |
| 71335-0807-4 | 71335080704 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0807-4) | 2018-07-16 | 0000-00-00 | No | No | Current |
| 71335-0807-5 | 71335080705 | 42 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0807-5) | 2024-07-09 | 0000-00-00 | No | No | Current |
| 71335-0807-6 | 71335080706 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0807-6) | 2024-07-09 | 0000-00-00 | No | No | Current |
| 71335-0807-7 | 71335080707 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0807-7) | 2024-07-09 | 0000-00-00 | No | No | Current |
| 71335-0807-8 | 71335080708 | 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0807-8) | 2024-07-09 | 0000-00-00 | No | No | Current |