Prilosec OTC
- Product NDC
- 37000-455
- 11-digit product format
- 370000455
- Labeler code
- 37000
- Product ID
- 37000-455_5d190a09-ce01-a20f-e063-6294a90a9003
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- omeprazole magnesium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- NDA021229
- Marketing category
- NDA
- Marketing start
- 2003-07-14
- 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
- 2027-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Dataset | Scope | Package NDC |
|---|---|---|
| excluded product | product | |
| excluded package | package | 37000-455-04 |
| excluded package | package | 37000-455-02 |
| excluded package | package | 37000-455-05 |
| excluded package | package | 37000-455-01 |
| excluded package | package | 37000-455-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021229-001 | PRILOSEC OTC | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2003-06-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2003-06-20 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021229-001 | PRILOSEC OTC | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2003-06-20 | 3a93d1ddd44b… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021229-001 | 6428810 | 2019-11-03 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021229-001 | 6403616 | 2019-11-15 | 74a2ff9319b5… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021229-001 | 6428810 | 2019-11-03 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021229-001 | 6403616 | 2019-11-15 | 3f01610625f2… | |||
| 2019-09-15 20:21 UTC | 2019-09 | N021229-001 | 6428810 | 2019-11-03 | b00525d2431f… | |||
| 2019-09-15 20:21 UTC | 2019-09 | N021229-001 | 6403616 | 2019-11-15 | b00525d2431f… | |||
| 2019-07-19 19:46 UTC | 2019-07 | N021229-001 | 6428810 | 2019-11-03 | ea99ee380514… | |||
| 2019-07-19 19:46 UTC | 2019-07 | N021229-001 | 6403616 | 2019-11-15 | ea99ee380514… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Prilosec OTC
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OMEPRAZOLE MAGNESIUM | 20.6 mg/1 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37000-455-01 | Prilosec OTC | 1 in 1 POUCH | TABLET, DELAYED RELEASE | 1 | 16 | |
| 37000-455-02 | Prilosec OTC | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | 16 | |
| 37000-455-02 | Prilosec OTC | 14 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 14 | 16 | |
| 37000-455-03 | Prilosec OTC | 2 in 1 CARTON | TABLET, DELAYED RELEASE | 2 | 16 | |
| 37000-455-03 | Prilosec OTC | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | 16 | |
| 37000-455-04 | Prilosec OTC | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | 16 | |
| 37000-455-04 | Prilosec OTC | 3 in 1 CARTON | TABLET, DELAYED RELEASE | 3 | 16 | |
| 37000-455-05 | Prilosec OTC | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 37000-455-02 | EA - Each | 37000-455 | 83d26bbf-1b1f-4662-839b-27147bd01cd9 | 1 | 2012-07-24 |
| 37000-455-03 | EA - Each | 37000-455 | f89a1e94-a00b-423d-bf01-2f9fc14a259b | 1 | 2012-07-24 |
| 37000-455-04 | EA - Each | 37000-455 | 32829c14-995e-4463-9139-48bea577867e | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 402014 | omeprazole 20 MG Delayed Release Oral Tablet | PSN | 77ed80a2-a482-4838-ac55-4865b5c31d9f | 16 |
| 608796 | PriLOSEC OTC 20 MG Delayed Release Oral Tablet | PSN | 77ed80a2-a482-4838-ac55-4865b5c31d9f | 16 |
| 608796 | omeprazole 20 MG Delayed Release Oral Tablet [Prilosec] | SBD | 77ed80a2-a482-4838-ac55-4865b5c31d9f | 16 |
| 402014 | omeprazole 20 MG Delayed Release Oral Tablet | SCD | 77ed80a2-a482-4838-ac55-4865b5c31d9f | 16 |
| 402014 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet | SY | 77ed80a2-a482-4838-ac55-4865b5c31d9f | 16 |
| 608796 | Prilosec 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet | SY | 77ed80a2-a482-4838-ac55-4865b5c31d9f | 16 |
| 608796 | Prilosec OTC 20 MG Delayed Release Oral Tablet | SY | 77ed80a2-a482-4838-ac55-4865b5c31d9f | 16 |
| 402014 | omeprazole 20 MG Delayed Release Oral Tablet | PSN | 6ceb26ec-7ae4-45d5-96d1-82439273613b | 1 |
| 608796 | PriLOSEC OTC 20 MG Delayed Release Oral Tablet | PSN | 6ceb26ec-7ae4-45d5-96d1-82439273613b | 1 |
| 608796 | omeprazole 20 MG Delayed Release Oral Tablet [Prilosec] | SBD | 6ceb26ec-7ae4-45d5-96d1-82439273613b | 1 |
| 402014 | omeprazole 20 MG Delayed Release Oral Tablet | SCD | 6ceb26ec-7ae4-45d5-96d1-82439273613b | 1 |
| 402014 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet | SY | 6ceb26ec-7ae4-45d5-96d1-82439273613b | 1 |
| 608796 | Prilosec 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet | SY | 6ceb26ec-7ae4-45d5-96d1-82439273613b | 1 |
| 608796 | Prilosec OTC 20 MG Delayed Release Oral Tablet | SY | 6ceb26ec-7ae4-45d5-96d1-82439273613b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37000-455-01 | 37000045501 | 1 TABLET, DELAYED RELEASE in 1 POUCH (37000-455-01) | 2003-07-14 | 0000-00-00 | No | No | Current | |
| 37000-455-02 | 37000045502 | 1 BLISTER PACK in 1 CARTON (37000-455-02) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 1 blister pack | 2003-07-14 | 0000-00-00 | No | No | Current |
| 37000-455-03 | 37000045503 | 2 CARTON in 1 CARTON (37000-455-03) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 2 carton | 2003-07-14 | 0000-00-00 | No | No | Current |
| 37000-455-04 | 37000045504 | 3 CARTON in 1 CARTON (37000-455-04) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 3 carton | 2003-07-14 | 0000-00-00 | No | No | Current |
| 37000-455-05 | 37000045505 | 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (37000-455-05) | 2003-07-14 | 0000-00-00 | No | No | Current |