NEXIUM
- Product NDC
- 61919-509
- 11-digit product format
- 619190509
- Labeler code
- 61919
- Product ID
- 61919-509_852cc99f-e417-0017-e053-2991aa0af97b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- esomeprazole magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- NDA021153
- Marketing category
- NDA
- Marketing start
- 2014-01-01
- Marketing end
- 0000-00-00
- Substance
- ESOMEPRAZOLE MAGNESIUM
- Active strength
- 40 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61919-509-30 | NEXIUM | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 3 |
| 61919-509-60 | NEXIUM | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESOMEPRAZOLE MAGNESIUM | ACTIVE INGREDIENT | R6DXU4WAY9 | NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| ESOMEPRAZOLE | ACTIVE MOIETY | N3PA6559FT | NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| ANHYDROUS DEXTROSE | INACTIVE INGREDIENT | 5SL0G7R0OK | NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| METHACRYLIC ACID | INACTIVE INGREDIENT | 1CS02G8656 | NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-509 | NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECT RX] | 3 | Legacy NDC, 2 package rows | 20190330_adaf210b-9a04-42f0-8887-2e1252efd1e2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 61919-509-30 | 61919050930 | 30 in 1 BOTTLE | Historical |
| 61919-509-60 | 61919050960 | 60 in 1 BOTTLE | Historical |