Omeprazole Magnesium
- Product NDC
- 49035-397
- 11-digit product format
- 490350397
- Labeler code
- 49035
- Product ID
- 49035-397_97152121-a5b6-df47-194e-c090f573c502
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole Magnesium 20.6mg Capsules
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Wal-Mart Stores Inc
- Application
- ANDA078878
- Marketing category
- ANDA
- Marketing start
- 2010-01-15
- Substance
- OMEPRAZOLE MAGNESIUM
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078878-001 | OMEPRAZOLE MAGNESIUM | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A078878-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RS | 2009-06-05 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omeprazole Magnesium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OMEPRAZOLE MAGNESIUM | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 426QFE7XLK | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198051 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3160e212-9ee9-8316-f51e-4628862f654c | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Omeprazole Magnesium | OMEPRAZOLE MAGNESIUM | Gericare Pharmaceuticals | 0e1f5d7c-5956-3be7-e054-00144ff8d46c | 2025-07-28 | Warnings | 078878 ANDA078878 |
| Omeprazole Magnesium | OMEPRAZOLE MAGNESIUM | HEB | 5d8b3f5f-f680-64ae-b360-c0bd06b2ac92 | 2025-07-23 | Warnings | 078878 ANDA078878 |
| Omeprazole Magnesium | OMEPRAZOLE MAGNESIUM | CVS Health Corp. | 3bbfa87d-f8b7-19bd-9f12-39cba31ae0b3 | 2025-07-23 | Warnings | 078878 ANDA078878 |
| Omeprazole Magnesium | OMEPRAZOLE MAGNESIUM | Chain Drug Marketing Association | ab5d339b-2c02-611d-d5db-8e1891684fe0 | 2025-07-23 | Warnings | 078878 ANDA078878 |
| Acid Reducer | OMEPRAZOLE MAGNESIUM | LEADER/ Cardinal Health 110, Inc. | 1dc00f13-d1f5-15a0-32cc-4fc041865e72 | 2025-07-23 | Warnings | 078878 ANDA078878 |
| Omeprazole Magnesium | OMEPRAZOLE MAGNESIUM | Albertsons Companies | 302b1332-181b-834b-4154-d849cb3a1ef0 | 2025-07-23 | Warnings | 078878 ANDA078878 |
| Omeprazole Magnesium | OMEPRAZOLE MAGNESIUM | Discount Drug Mart, Inc | daeeba93-29d5-efb4-a591-3e72c4e50341 | 2025-07-23 | Warnings | 078878 ANDA078878 |
| Omeprazole Magnesium | OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES | The Kroger Co. | 8a6bbc31-7c50-a730-4233-e346fd7eb5ba | 2025-07-22 | Warnings | 078878 ANDA078878 |
| Omeprazole Magnesium | OMEPRAZOLE MAGNESIUM | Dr. Reddy's Laboratories Inc. | fe0eb905-2042-aed1-a67d-a219e76f679b | 2025-07-22 | Warnings | 078878 ANDA078878 |
| Omeprazole Magnesium | OMEPRAZOLE MAGNESIUM | Walgreens Company | ee8b1740-9bcf-5b70-bd8d-97f98303dc72 | 2025-07-22 | Warnings | 078878 ANDA078878 |
| Omeprazole Magnesium | OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES | Wal-Mart Stores Inc | 3160e212-9ee9-8316-f51e-4628862f654c | 2025-07-22 | Warnings | 078878 ANDA078878 49035-397 |
| Omeprazole Magnesium | OMEPRAZOLE MAGNESIUM | Chain Drug Consortium, LLC | 39ac65c0-d957-125f-f00b-e3846a437489 | 2025-07-22 | Warnings | 078878 ANDA078878 |
| Omeprazole Magnesium | OMEPRAZOLE MAGNESIUM | Chain Drug Marketing Association | fdf1259b-e9d3-70a9-c209-e2eb6b152841 | 2025-07-22 | Warnings | 078878 ANDA078878 |
| Omeprazole Magnesium | OMEPRAZOLE MAGNESIUM | Dr. Reddy's Laboratories Limited | 0e8fde83-a55c-edaf-3c66-e1fc77d0bc11 | 2025-05-28 | Warnings | 078878 ANDA078878 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 3160e212-9ee9-8316-f51e-4628862f654c | 9 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 3160e212-9ee9-8316-f51e-4628862f654c | 9 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 3160e212-9ee9-8316-f51e-4628862f654c | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49035-397-27 | 49035039727 | 2 BOTTLE in 1 CARTON (49035-397-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 2 bottle | 2010-01-15 | 0000-00-00 | No | No | Current |
| 49035-397-33 | 49035039733 | 3 BOTTLE in 1 CARTON (49035-397-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2010-01-15 | 0000-00-00 | No | No | Current |
| 49035-397-52 | 49035039752 | 1 BOTTLE in 1 CARTON (49035-397-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2010-01-15 | 0000-00-00 | No | No | Current |