Esomeprazole Magnesium
- Product NDC
- 16714-980
- 11-digit product format
- 167140980
- Labeler code
- 16714
- Product ID
- 16714-980_0db3d40a-29ae-8151-d2cb-2a75c0573a1b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA078279
- Marketing category
- ANDA
- Marketing start
- 2019-09-17
- 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 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 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 |
|---|---|---|---|---|---|---|
| 16714-980-01 | Esomeprazole Magnesium | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 5 | |
| 16714-980-02 | Esomeprazole Magnesium | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | 5 | |
| 16714-980-03 | Esomeprazole Magnesium | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16714-980-01 | EA - Each | 16714-980 | c1687e30-fed0-46b1-91cd-c86663ec36e8 | 1 | 2020-02-13 |
| 16714-980-02 | EA - Each | 16714-980 | e93b6d87-f63d-4e3f-b1e1-a6300097a141 | 1 | 2020-02-13 |
| 16714-980-03 | EA - Each | 16714-980 | 50f5283b-68a2-430f-aa9d-f1ec6f1495ff | 1 | 2022-02-07 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 606726 | esomeprazole magnesium 20 MG Delayed Release Oral Capsule | PSN | 380da8db-bfa3-8c0c-f8f3-573675fed981 | 5 |
| 606730 | esomeprazole magnesium 40 MG Delayed Release Oral Capsule | PSN | 380da8db-bfa3-8c0c-f8f3-573675fed981 | 5 |
| 606730 | esomeprazole magnesium 40 MG Delayed Release Oral Capsule | PSN | 71956762-d2f7-4763-9afe-1ca8f32a3cbb | 5 |
| 606726 | esomeprazole 20 MG Delayed Release Oral Capsule | SCD | 380da8db-bfa3-8c0c-f8f3-573675fed981 | 5 |
| 606730 | esomeprazole 40 MG Delayed Release Oral Capsule | SCD | 380da8db-bfa3-8c0c-f8f3-573675fed981 | 5 |
| 606730 | esomeprazole 40 MG Delayed Release Oral Capsule | SCD | 71956762-d2f7-4763-9afe-1ca8f32a3cbb | 5 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule | SY | 380da8db-bfa3-8c0c-f8f3-573675fed981 | 5 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule | SY | 380da8db-bfa3-8c0c-f8f3-573675fed981 | 5 |
| 606730 | esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule | SY | 380da8db-bfa3-8c0c-f8f3-573675fed981 | 5 |
| 606730 | esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule | SY | 71956762-d2f7-4763-9afe-1ca8f32a3cbb | 5 |
| 606730 | esomeprazole magnesium 40 MG Delayed Release Oral Capsule | PSN | 463c9b3b-dd6b-7ee7-e063-6394a90afb43 | 1 |
| 606730 | esomeprazole magnesium 40 MG Delayed Release Oral Capsule | PSN | f2f6a6a4-9efc-25f4-e053-2995a90adfc3 | 1 |
| 606730 | esomeprazole magnesium 40 MG Delayed Release Oral Capsule | PSN | 99fceec8-59a2-485f-a7f3-7c5afd98401d | 1 |
| 606730 | esomeprazole 40 MG Delayed Release Oral Capsule | SCD | 463c9b3b-dd6b-7ee7-e063-6394a90afb43 | 1 |
| 606730 | esomeprazole 40 MG Delayed Release Oral Capsule | SCD | f2f6a6a4-9efc-25f4-e053-2995a90adfc3 | 1 |
| 606730 | esomeprazole 40 MG Delayed Release Oral Capsule | SCD | 99fceec8-59a2-485f-a7f3-7c5afd98401d | 1 |
| 606730 | esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule | SY | 99fceec8-59a2-485f-a7f3-7c5afd98401d | 1 |
| 606730 | esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule | SY | 463c9b3b-dd6b-7ee7-e063-6394a90afb43 | 1 |
| 606730 | esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule | SY | f2f6a6a4-9efc-25f4-e053-2995a90adfc3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 16714-980-01 | 16714098001 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-980-01) | 2019-09-17 | 0000-00-00 | No | No | Current |
| 16714-980-02 | 16714098002 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-980-02) | 2019-09-17 | 0000-00-00 | No | No | Current |
| 16714-980-03 | 16714098003 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-980-03) | 2021-11-22 | 0000-00-00 | No | No | Current |