Escitalopram Oxalate
- Product NDC
- 53746-019
- 11-digit product format
- 537460019
- Labeler code
- 53746
- Product ID
- 53746-019_fe4fad91-a1c2-41f2-933d-94bdfb86d38c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Escitalopram Oxalate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA205619
- Marketing category
- ANDA
- Marketing start
- 2017-05-17
- Substance
- ESCITALOPRAM OXALATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Escitalopram Oxalate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESCITALOPRAM OXALATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5U85DBW7LO |
| Rxcui | 349332, 351249, 351250 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53746-019-05 | Escitalopram Oxalate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
| 53746-019-10 | Escitalopram Oxalate | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
| 53746-019-30 | Escitalopram Oxalate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 53746-019-90 | Escitalopram Oxalate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-019 | ESCITALOPRAM OXALATE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 3 | Current NDC, 4 package rows | 20241127_4f941d7a-5abb-4907-a7a1-480245deef87.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 53746-019-05 | 53746001905 | 500 TABLET, FILM COATED in 1 BOTTLE (53746-019-05) | 2017-05-17 | No | No | Current |
| 53746-019-10 | 53746001910 | 1000 TABLET, FILM COATED in 1 BOTTLE (53746-019-10) | 2017-05-17 | No | No | Current |
| 53746-019-30 | 53746001930 | 30 TABLET, FILM COATED in 1 BOTTLE (53746-019-30) | 2017-05-17 | No | No | Current |
| 53746-019-90 | 53746001990 | 90 TABLET, FILM COATED in 1 BOTTLE (53746-019-90) | 2017-05-17 | No | No | Current |