Esomeprazole magnesium
- Product NDC
- 63304-735
- 11-digit product format
- 633040735
- Labeler code
- 63304
- Product ID
- 63304-735_6d8e57e7-6cc5-4edc-8a4e-47ab7fdae397
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc
- Application
- ANDA209735
- Marketing category
- ANDA
- Marketing start
- 2025-09-18
- Substance
- ESOMEPRAZOLE MAGNESIUM
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Esomeprazole magnesium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESOMEPRAZOLE MAGNESIUM | 40 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | R6DXU4WAY9 |
| Rxcui | 606726, 606730 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7006a36-e68d-42e2-8cd3-d725cb2e47b1 | Product name | 6 | 20251027 |
| d71865e8-5c35-4d76-8ecd-a7adda982240 | Product name | 9 | 20180628 |
| d71865e8-5c35-4d76-8ecd-a7adda982240 | Product name | 8 | 20171212 |
| 094c6751-235c-4d12-acee-2baf94f676f4 | Product name | 1 | 20151116 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63304-735-10 | Esomeprazole magnesium | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | 8 | |
| 63304-735-30 | Esomeprazole magnesium | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 8 | |
| 63304-735-90 | Esomeprazole magnesium | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63304-735-10 | EA - Each | 63304-735 | e2941142-bff7-499d-b8a6-c0ef5844502f | 1 | 2019-06-19 |
| 63304-735-30 | EA - Each | 63304-735 | 43a10bd8-9596-4d00-a316-56e106315c06 | 1 | 2019-06-19 |
| 63304-735-90 | EA - Each | 63304-735 | e2c0ce70-7b3f-461b-929b-c1fa28a14791 | 1 | 2019-06-19 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 606730 | esomeprazole magnesium 40 MG Delayed Release Oral Capsule | PSN | 6ee83d0e-6566-4cb0-a9bd-8a11a149d78f | 103 |
| 606730 | esomeprazole 40 MG Delayed Release Oral Capsule | SCD | 6ee83d0e-6566-4cb0-a9bd-8a11a149d78f | 103 |
| 606730 | esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule | SY | 6ee83d0e-6566-4cb0-a9bd-8a11a149d78f | 103 |
| 606726 | esomeprazole magnesium 20 MG Delayed Release Oral Capsule | PSN | dc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf | 8 |
| 606730 | esomeprazole magnesium 40 MG Delayed Release Oral Capsule | PSN | dc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf | 8 |
| 606726 | esomeprazole 20 MG Delayed Release Oral Capsule | SCD | dc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf | 8 |
| 606730 | esomeprazole 40 MG Delayed Release Oral Capsule | SCD | dc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf | 8 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule | SY | dc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf | 8 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule | SY | dc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf | 8 |
| 606730 | esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule | SY | dc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf | 8 |
| 606726 | esomeprazole magnesium 20 MG Delayed Release Oral Capsule | PSN | 43cf2754-3ec7-75f7-e063-6394a90adfeb | 1 |
| 606730 | esomeprazole magnesium 40 MG Delayed Release Oral Capsule | PSN | 43cf2754-3ec7-75f7-e063-6394a90adfeb | 1 |
| 606726 | esomeprazole 20 MG Delayed Release Oral Capsule | SCD | 43cf2754-3ec7-75f7-e063-6394a90adfeb | 1 |
| 606730 | esomeprazole 40 MG Delayed Release Oral Capsule | SCD | 43cf2754-3ec7-75f7-e063-6394a90adfeb | 1 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule | SY | 43cf2754-3ec7-75f7-e063-6394a90adfeb | 1 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule | SY | 43cf2754-3ec7-75f7-e063-6394a90adfeb | 1 |
| 606730 | esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule | SY | 43cf2754-3ec7-75f7-e063-6394a90adfeb | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63304-735-10 | 63304073510 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63304-735-10) | 2025-09-18 | 0000-00-00 | No | No | Current |
| 63304-735-30 | 63304073530 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63304-735-30) | 2025-09-18 | 0000-00-00 | No | No | Current |
| 63304-735-90 | 63304073590 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63304-735-90) | 2025-09-18 | 0000-00-00 | No | No | Current |