Omeprazole
- Product NDC
- 63548-4080
- 11-digit product format
- 635484080
- Labeler code
- 63548
- Product ID
- 63548-4080_8289695b-99ab-44e6-a237-da93ec951d1e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- PLD Acquisitions LLC DBA Av�ma Pharma Solutions
- Application
- ANDA206582
- Marketing category
- ANDA
- Marketing start
- 2024-10-31
- Substance
- OMEPRAZOLE MAGNESIUM
- Active strength
- 20.6 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 |
|---|---|---|---|---|---|---|---|
| A206582-001 | OMEPRAZOLE MAGNESIUM | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 |
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 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206582-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2020-06-01 | a50c72e98297… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omeprazole
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OMEPRAZOLE MAGNESIUM | 20.6 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 426QFE7XLK | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 402014 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6a1aeb95-5760-4363-816a-fa8305979c50 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 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 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
| ed912195-5da0-0f2f-6f4b-3ef17710cbe3 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63548-4080-2 | Omeprazole | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | 1 | |
| 63548-4080-2 | Omeprazole | 42 in 1 CARTON | TABLET, DELAYED RELEASE | 42 | 1 | |
| 63548-4080-4 | Omeprazole | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | 1 | |
| 63548-4080-4 | Omeprazole | 14 in 1 CARTON | TABLET, DELAYED RELEASE | 14 | 1 | |
| 63548-4080-8 | Omeprazole | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | 1 | |
| 63548-4080-8 | Omeprazole | 28 in 1 CARTON | TABLET, DELAYED RELEASE | 28 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63548-4080 | OMEPRAZOLE TABLET, DELAYED RELEASE [PLD ACQUISITIONS LLC DBA AVÉMA PHARMA SOLUTIONS] | 1 | Current NDC, 6 package rows | 20241101_6a1aeb95-5760-4363-816a-fa8305979c50.zip |
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 |
|---|---|---|---|---|---|---|
| Prilosec OTC | OMEPRAZOLE MAGNESIUM | The Procter & Gamble Manufacturing Company | 37291cab-e350-d8e3-e063-6294a90a9cb1 | 2026-07-29 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | P & L Development, LLC | 883e428a-e157-4bbf-8657-e7a93dc99e8c | 2026-07-14 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | WALMART INC. (see also Equate) | d3c1ba08-680d-4e39-875c-1f1d42ae787c | 2026-07-13 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | PLD Acquisitions LLC DBA Avma Pharma Solutions | d9c8a242-bdba-4f92-8629-692b47ebba21 | 2026-06-26 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | PLD Acquisitions LLC DBA Avma Pharma Solutions | 71add294-ff24-4bbf-9067-7c56ed7c9f1a | 2026-06-26 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | PLD Acquisitions LLC DBA Avma Pharma Solutions | e67bf2c6-0618-48e0-aa08-705501d86431 | 2026-06-26 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | PLD Acquisitions LLC DBA Avma Pharma Solutions | 6a1aeb95-5760-4363-816a-fa8305979c50 | 2026-06-26 | Warnings | 206582 ANDA206582 63548-4080 |
| Omeprazole | OMEPRAZOLE | P & L Development, LLC | 911a08c4-ba73-4600-a5f2-7f26ba8c8604 | 2026-06-25 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | Walgreens | b9683a94-fd44-4364-be0e-477ca1a29aba | 2026-03-27 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | WinCo Foods, LLC | 2782b98b-50e4-4a4e-8626-d34ebfd71bfb | 2026-01-14 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | Family Dollar (FAMILY WELLNESS) | f2195d73-1fd5-4de2-aa5c-18741d11f4fc | 2025-10-30 | Warnings | 206582 ANDA206582 |
| Prilosec OTC | OMEPRAZOLE MAGNESIUM | The Procter & Gamble Manufacturing Company | c7229a69-07e7-4690-8fc0-1f0f093bf230 | 2025-06-10 | Warnings | 206582 ANDA206582 |
| Omeprazole | OMEPRAZOLE | P & L Development, LLC | 44a92926-1941-4fe8-9b2a-31a45289456f | 2025-06-02 | Warnings | 206582 ANDA206582 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 402014 | omeprazole 20 MG Delayed Release Oral Tablet | PSN | 6a1aeb95-5760-4363-816a-fa8305979c50 | 1 |
| 402014 | omeprazole 20 MG Delayed Release Oral Tablet | SCD | 6a1aeb95-5760-4363-816a-fa8305979c50 | 1 |
| 402014 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet | SY | 6a1aeb95-5760-4363-816a-fa8305979c50 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63548-4080-2 | 63548408002 | 42 BLISTER PACK in 1 CARTON (63548-4080-2) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 42 blister pack | 2024-10-31 | No | No | Current |
| 63548-4080-4 | 63548408004 | 14 BLISTER PACK in 1 CARTON (63548-4080-4) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 14 blister pack | 2024-10-31 | No | No | Current |
| 63548-4080-8 | 63548408008 | 28 BLISTER PACK in 1 CARTON (63548-4080-8) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 28 blister pack | 2024-10-31 | No | No | Current |