Omeprazole
- Product NDC
- 55111-159
- 11-digit product format
- 551110159
- Labeler code
- 55111
- Product ID
- 55111-159_0dc50704-e0d5-1fcc-b0b5-6e5556db65e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA075576
- Marketing category
- ANDA
- Marketing start
- 2009-01-21
- Substance
- OMEPRAZOLE
- Active strength
- 40 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 |
|---|---|---|---|---|---|---|---|
| A075576-001 | OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | |
| A075576-002 | OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | |
| A075576-003 | OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075576-001 | AB |
| A075576-002 | AB |
| A075576-003 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A075576-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075576-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075576-003 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Omeprazole | OMEPRAZOLE | St. Mary's Medical Park Pharmacy | 1eb57c13-25ed-70bc-e063-6294a90afdac | 2026-06-10 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Northwind Health Company, LLC | aae3bf9f-5d05-889f-e053-2995a90a5ff2 | 2025-12-26 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | QPharma, Inc. | f5dcf0b2-4fa2-023a-e053-2995a90a183a | 2025-12-01 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Quallent Pharmaceuticals Health LLC | 665e9877-85ac-fdb6-54ac-1c47941ceab8 | 2025-11-28 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | PD-Rx Pharmaceuticals, Inc. | e235ef89-3592-4ca1-8c13-d7ce84b1001c | 2025-10-16 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | American Health Packaging | a17e415e-a559-4a8d-a455-699184a01523 | 2025-02-17 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole DR | OMEPRAZOLE | Advanced Rx of Tennessee, LLC | af85e324-ef9f-196c-e053-2995a90a384e | 2024-12-31 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Quality Care Products, LLC | 581d1c3d-457a-41f2-8db0-5b6219cdcb09 | 2024-12-16 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | f0f61a89-700d-481d-9255-6f9a9afa7025 | 2024-10-01 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Advanced Rx of Tennessee, LLC | 1d4ecc1e-5180-f75e-e063-6394a90a51a6 | 2024-07-15 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | e1f20429-cfaa-420b-a65a-271be37eb799 | 2024-05-28 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Dr. Reddy's Laboratories Limited | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 2024-04-15 | Warnings, Adverse reactions | 075576 ANDA075576 55111-159 |
| Omeprazole | OMEPRAZOLE | A-S Medication Solutions | b129fe93-c8a2-4ae8-ad1b-8f9ae5779b68 | 2023-09-10 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | NorthStar Rx LLC | c5af5f4b-17be-7245-b281-f27c87831242 | 2023-06-20 | Warnings, Adverse reactions | 075576 ANDA075576 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omeprazole
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OMEPRAZOLE | 40 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| KG60484QX9 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 72fb11b6-b08c-2f02-d82b-f60f52394903 | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55111-159-01 | Omeprazole | 100 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 100 | 28 | |
| 55111-159-05 | Omeprazole | 500 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 500 | 28 | |
| 55111-159-10 | Omeprazole | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | 28 | |
| 55111-159-30 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 28 | |
| 55111-159-78 | Omeprazole | 10 in 1 CARTON | CAPSULE, DELAYED RELEASE | 10 | 28 | |
| 55111-159-79 | Omeprazole | 10 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 10 | 28 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55111-159-01 | EA - Each | 55111-159 | ee2624e7-a2dd-48b2-af57-d1ddd58d4928 | 1 | 2013-02-13 |
| 55111-159-05 | EA - Each | 55111-159 | f212a26a-f031-46dd-bfe3-af29cbdc6096 | 1 | 2013-02-13 |
| 55111-159-10 | EA - Each | 55111-159 | 57704bb2-fadc-4d27-b353-1367183bbf45 | 1 | 2024-09-09 |
| 55111-159-30 | EA - Each | 55111-159 | c765395c-fb1e-45da-bea7-479f4311ea1d | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | PSN | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 28 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 28 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 28 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | SCD | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 28 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 28 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 28 |
| 199119 | omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule | SY | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 28 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 28 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | c63b2dd4-ac8a-47a1-889b-94d68137bd01 | 6 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | c63b2dd4-ac8a-47a1-889b-94d68137bd01 | 6 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 93ec1327-22b1-4a5d-a793-e014f6dffd33 | 1 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | f30c4317-bb6a-452d-b1aa-78dbd09c3833 | 1 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 93ec1327-22b1-4a5d-a793-e014f6dffd33 | 1 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | f30c4317-bb6a-452d-b1aa-78dbd09c3833 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55111-159-01 | 55111015901 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-159-01) | 2009-01-21 | 0000-00-00 | No | No | Current | |
| 55111-159-05 | 55111015905 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-159-05) | 2009-01-21 | 0000-00-00 | No | No | Current | |
| 55111-159-10 | 55111015910 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-159-10) | 2024-06-19 | No | No | Current | ||
| 55111-159-30 | 55111015930 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-159-30) | 2009-01-21 | 0000-00-00 | No | No | Current | |
| 55111-159-78 | 55111015978 | 10 BLISTER PACK in 1 CARTON (55111-159-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-159-79) | 10 blister pack | 2009-01-21 | 0000-00-00 | No | No | Current |
| 55111-159-79 | 55111015979 | 10 in 1 BLISTER PACK | Historical |