Esomeprazole Magnesium
- Product NDC
- 71335-1170
- 11-digit product format
- 713351170
- Labeler code
- 71335
- Product ID
- 71335-1170_e83812c6-e48e-4f50-93cf-a3777695c51a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205563
- Marketing category
- ANDA
- Marketing start
- 2017-09-01
- Substance
- ESOMEPRAZOLE 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Esomeprazole Magnesium
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESOMEPRAZOLE MAGNESIUM | 20 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | R6DXU4WAY9 |
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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71335-1170-1 | Esomeprazole Magnesium | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 30 | 7 | |
| 71335-1170-2 | Esomeprazole Magnesium | 10 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 10 | 7 | |
| 71335-1170-3 | Esomeprazole Magnesium | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 60 | 7 | |
| 71335-1170-4 | Esomeprazole Magnesium | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 90 | 7 | |
| 71335-1170-5 | Esomeprazole Magnesium | 42 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 42 | 7 | |
| 71335-1170-6 | Esomeprazole Magnesium | 120 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 120 | 7 | |
| 71335-1170-7 | Esomeprazole Magnesium | 180 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 180 | 7 | |
| 71335-1170-8 | Esomeprazole Magnesium | 20 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 20 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71335-1170 | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK] | 7 | Current NDC, Legacy NDC, 8 package rows | 20240522_fed0e554-7d61-4957-9b91-356f3abc0777.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 606726 | esomeprazole magnesium 20 MG Delayed Release Oral Capsule | PSN | fed0e554-7d61-4957-9b91-356f3abc0777 | 7 |
| 606726 | esomeprazole 20 MG Delayed Release Oral Capsule | SCD | fed0e554-7d61-4957-9b91-356f3abc0777 | 7 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule | SY | fed0e554-7d61-4957-9b91-356f3abc0777 | 7 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule | SY | fed0e554-7d61-4957-9b91-356f3abc0777 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71335-1170-1 | 71335117001 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-1) | 2019-03-25 | 0000-00-00 | No | No | Current |
| 71335-1170-2 | 71335117002 | 10 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-2) | 2019-07-01 | 0000-00-00 | No | No | Current |
| 71335-1170-3 | 71335117003 | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-3) | 2019-05-07 | 0000-00-00 | No | No | Current |
| 71335-1170-4 | 71335117004 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-4) | 2019-06-10 | 0000-00-00 | No | No | Current |
| 71335-1170-5 | 71335117005 | 42 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-5) | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1170-6 | 71335117006 | 120 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-6) | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1170-7 | 71335117007 | 180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-7) | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1170-8 | 71335117008 | 20 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-8) | 2019-09-04 | 0000-00-00 | No | No | Current |