ESOMEPRAZOLE MAGNESIUM
- Product NDC
- 13668-154
- 11-digit product format
- 136680154
- Labeler code
- 13668
- Product ID
- 13668-154_89387fd0-ce27-4f1a-a331-53c23ac58a23
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESOMEPRAZOLE MAGNESIUM
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA203636
- Marketing category
- ANDA
- Marketing start
- 2015-10-19
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7006a36-e68d-42e2-8cd3-d725cb2e47b1 | Product name | 6 | 20251027 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| d71865e8-5c35-4d76-8ecd-a7adda982240 | Product name | 9 | 20180628 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13668-154-10 | EA - Each | 13668-154 | f425864b-d001-493b-a003-5aab151ee684 | 1 | 2015-11-12 |
| 13668-154-30 | EA - Each | 13668-154 | 98b9c3c3-46c2-41e9-94f8-f71ed4e83214 | 1 | 2015-11-12 |
| 13668-154-90 | EA - Each | 13668-154 | e14926ed-5488-4550-aaa7-6c29c5f07d39 | 1 | 2015-11-12 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 606726 | esomeprazole magnesium 20 MG Delayed Release Oral Capsule | PSN | e6db8cb7-6c39-4692-a1ff-50f056946df9 | 9 |
| 606730 | esomeprazole magnesium 40 MG Delayed Release Oral Capsule | PSN | e6db8cb7-6c39-4692-a1ff-50f056946df9 | 9 |
| 606726 | esomeprazole 20 MG Delayed Release Oral Capsule | SCD | e6db8cb7-6c39-4692-a1ff-50f056946df9 | 9 |
| 606730 | esomeprazole 40 MG Delayed Release Oral Capsule | SCD | e6db8cb7-6c39-4692-a1ff-50f056946df9 | 9 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule | SY | e6db8cb7-6c39-4692-a1ff-50f056946df9 | 9 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule | SY | e6db8cb7-6c39-4692-a1ff-50f056946df9 | 9 |
| 606730 | esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule | SY | e6db8cb7-6c39-4692-a1ff-50f056946df9 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 13668-154-05 | 13668015405 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-154-05) | 2015-10-19 | 0000-00-00 | No | No | Current |
| 13668-154-10 | 13668015410 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-154-10) | 2015-10-19 | 0000-00-00 | No | No | Current |
| 13668-154-30 | 13668015430 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-154-30) | 2015-10-19 | 0000-00-00 | No | No | Current |
| 13668-154-74 | 13668015474 | 100 CAPSULE, DELAYED RELEASE in 1 CARTON (13668-154-74) | 2015-10-19 | 0000-00-00 | No | No | Current |
| 13668-154-90 | 13668015490 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-154-90) | 2015-10-19 | 0000-00-00 | No | No | Current |