ESOMEPRAZOLE MAGNESIUM
- Product NDC
- 61919-243
- 11-digit product format
- 619190243
- Labeler code
- 61919
- Product ID
- 61919-243_bc02753e-e56b-2a4c-e053-2a95a90ae1a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESOMEPRAZOLE MAGNESIUM
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA078003
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- 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
- 2022-12-31
- 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 |
|---|
| 61919-243-30 | ESOMEPRAZOLE MAGNESIUM | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 3 |
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 [DIRECT RX] | 2 | |
| ESOMEPRAZOLE | ACTIVE MOIETY | N3PA6559FT | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX] | 2 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX] | 2 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX] | 2 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX] | 2 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-243 | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX] | 3 | Legacy NDC, 1 package rows | 20210224_b846b3ca-231c-4a95-b028-136c5107fa57.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61919-243-30 | 61919024330 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-243-30) | 2021-02-24 | 0000-00-00 | No | No | Current |