Escitalopram
- Product NDC
- 59746-281
- 11-digit product format
- 597460281
- Labeler code
- 59746
- Product ID
- 59746-281_1ba045ea-2f59-4bf4-94b3-d03449c0bf77
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Escitalopram Oxalate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Jubilant Cadista Pharmacuticals Inc.
- Application
- ANDA202280
- Marketing category
- ANDA
- Marketing start
- 2024-01-01
- Substance
- ESCITALOPRAM OXALATE
- Active strength
- 20 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESCITALOPRAM OXALATE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5U85DBW7LO |
| Rxcui | 349332, 351249, 351250 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 59746-281-01 | 2023-11-28 | C162847 | 48780-1 | f386c649-9ce5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 |
| 59746-281-05 | 2023-11-28 | C162847 | 48780-1 | f386c649-9ce5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 |
| 59746-281-10 | 2023-11-28 | C162847 | 48780-1 | f386c649-9ce5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 |
| 59746-281-30 | 2023-11-28 | C162847 | 48780-1 | f386c649-9ce5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 |
| 59746-281-90 | 2023-11-28 | C162847 | 48780-1 | f386c649-9ce5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 |
| 59746-281-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-9ce5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 |
| 59746-281-05 | 2023-01-30 | C162847 | 48780-1 | f386c649-9ce5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 |
| 59746-281-10 | 2023-01-30 | C162847 | 48780-1 | f386c649-9ce5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 |
| 59746-281-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-9ce5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 |
| 59746-281-90 | 2023-01-30 | C162847 | 48780-1 | f386c649-9ce5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59746-281-01 | Escitalopram | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 14 |
| 59746-281-05 | Escitalopram | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 14 |
| 59746-281-10 | Escitalopram | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 14 |
| 59746-281-30 | Escitalopram | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 14 |
| 59746-281-90 | Escitalopram | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Escitalopram oxalate | ACTIVE INGREDIENT | 5U85DBW7LO | ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 8 | |
| Escitalopram | ACTIVE MOIETY | 4O4S742ANY | ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 8 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 8 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 8 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 8 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 8 | |
| Polyethylene Glycol 400 | INACTIVE INGREDIENT | B697894SGQ | ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 8 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 8 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 8 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59746-281 | ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 13 | Current NDC, Legacy NDC, 5 package rows | 20240206_2db02476-325f-ee47-a7e5-b5aed56c364c.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 |
|---|
| 59746-281-01 | 59746028101 | 100 TABLET, FILM COATED in 1 BOTTLE (59746-281-01) | 2024-01-01 | 0000-00-00 | No | No | Current |
| 59746-281-05 | 59746028105 | 500 TABLET, FILM COATED in 1 BOTTLE (59746-281-05) | 2024-01-01 | 0000-00-00 | No | No | Current |
| 59746-281-10 | 59746028110 | 1000 TABLET, FILM COATED in 1 BOTTLE (59746-281-10) | 2024-01-01 | 0000-00-00 | No | No | Current |
| 59746-281-30 | 59746028130 | 30 TABLET, FILM COATED in 1 BOTTLE (59746-281-30) | 2024-01-01 | 0000-00-00 | No | No | Current |
| 59746-281-90 | 59746028190 | 90 TABLET, FILM COATED in 1 BOTTLE (59746-281-90) | 2024-01-01 | 0000-00-00 | No | No | Current |