Esomeprazole Magnesium
- Product NDC
- 50436-3120
- 11-digit product format
- 504363120
- Labeler code
- 50436
- Product ID
- 50436-3120_50e2c3d5-7948-43bf-8995-5ea53105ef93
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA078003
- Marketing category
- ANDA
- Marketing start
- 2015-02-17
- Marketing end
- 0000-00-00
- Substance
- ESOMEPRAZOLE MAGNESIUM DIHYDRATE
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50436-3120-1 | Esomeprazole Magnesium | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESOMEPRAZOLE MAGNESIUM DIHYDRATE | ACTIVE INGREDIENT | 36H71644EQ | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | |
| ESOMEPRAZOLE | ACTIVE MOIETY | N3PA6559FT | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50436-3120 | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | Legacy NDC, 1 package rows | 20150627_1f0ba9c8-e5f2-4d65-a0e3-19a6541a03b5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 50436-3120-1 | 50436312001 | 30 in 1 BOTTLE | Historical |