ESOMEPRAZOLE STRONTIUM is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Parapro Llc. The primary component is Esomeprazole Strontium.
| Product ID | 52246-400_ccdb594f-adc9-4913-aa67-571bba802914 |
| NDC | 52246-400 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ESOMEPRAZOLE STRONTIUM |
| Generic Name | Esomeprazole Strontium |
| Dosage Form | Capsule, Delayed Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2016-10-28 |
| Marketing Category | NDA / NDA |
| Application Number | NDA202342 |
| Labeler Name | ParaPRO LLC |
| Substance Name | ESOMEPRAZOLE STRONTIUM |
| Active Ingredient Strength | 49 mg/1 |
| Pharm Classes | Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2016-10-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA202342 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-10-28 |
| Marketing End Date | 2019-09-30 |
| Ingredient | Strength |
|---|---|
| ESOMEPRAZOLE STRONTIUM | 49.3 mg/1 |
| SPL SET ID: | 53240ab5-98e7-4050-b640-e09c1271899a |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 52246-400 | ESOMEPRAZOLE STRONTIUM | esomeprazole strontium |
| 53746-955 | Esomeprazole strontium | Esomeprazole strontium |
| 53746-957 | Esomeprazole strontium | Esomeprazole strontium |
| 65162-955 | Esomeprazole strontium | Esomeprazole strontium |
| 65162-957 | Esomeprazole strontium | Esomeprazole strontium |
| 69336-129 | Esomeprazole strontium | Esomeprazole strontium |
| 70849-200 | ESOMEPRAZOLE STRONTIUM | esomeprazole strontium |
| 70849-400 | ESOMEPRAZOLE STRONTIUM | esomeprazole strontium |