Esomeprazole Magnesium
- Product NDC
- 16714-979
- 11-digit product format
- 167140979
- Labeler code
- 16714
- Product ID
- 16714-979_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
- 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
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 |
|---|---|---|---|---|---|---|
| 16714-979-01 | Esomeprazole Magnesium | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 5 | |
| 16714-979-02 | Esomeprazole Magnesium | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16714-979-01 | EA - Each | 16714-979 | aeef371e-ab2f-4859-9974-c8be4d8c28f8 | 1 | 2020-02-13 |
| 16714-979-02 | EA - Each | 16714-979 | 347d8a61-3ed0-4eb2-a30f-1bfde6075a06 | 1 | 2020-02-13 |
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 |
| 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 |
| 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 |
| 606726 | esomeprazole magnesium 20 MG Delayed Release Oral Capsule | PSN | 2879c79f-bf2a-0bc9-e063-6394a90a98ae | 2 |
| 606726 | esomeprazole 20 MG Delayed Release Oral Capsule | SCD | 2879c79f-bf2a-0bc9-e063-6394a90a98ae | 2 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule | SY | 2879c79f-bf2a-0bc9-e063-6394a90a98ae | 2 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule | SY | 2879c79f-bf2a-0bc9-e063-6394a90a98ae | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 16714-979-01 | 16714097901 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-979-01) | 2019-09-17 | 0000-00-00 | No | No | Current |
| 16714-979-02 | 16714097902 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-979-02) | 2019-09-17 | 0000-00-00 | No | No | Current |