Escitalopram
- Product NDC
- 68258-7128
- 11-digit product format
- 682587128
- Labeler code
- 68258
- Product ID
- 68258-7128_c36c58df-fc65-4072-ac8c-3b168c2bcd1b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Escitalopram
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dispensing Solutions, Inc.
- Application
- ANDA078766
- Marketing category
- ANDA
- Marketing start
- 2012-09-11
- Marketing end
- 0000-00-00
- Substance
- ESCITALOPRAM OXALATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68258-7128-3 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d343-cd31-e053-dbdaa90ab51a | These highlights do not include all the information needed to use Escitalopram Tablets, USP safely and effectively. See full prescribing information for Escitalopram Tablets, USP. Escitalopram Tablets, USP 5 mg, 10 mg and 20 mg for Oral use Initial U.S. Approval: 2002 |
| 68258-7128-6 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d343-cd31-e053-dbdaa90ab51a | These highlights do not include all the information needed to use Escitalopram Tablets, USP safely and effectively. See full prescribing information for Escitalopram Tablets, USP. Escitalopram Tablets, USP 5 mg, 10 mg and 20 mg for Oral use Initial U.S. Approval: 2002 |
| 68258-7128-9 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d343-cd31-e053-dbdaa90ab51a | These highlights do not include all the information needed to use Escitalopram Tablets, USP safely and effectively. See full prescribing information for Escitalopram Tablets, USP. Escitalopram Tablets, USP 5 mg, 10 mg and 20 mg 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 |
|---|
| 68258-7128-3 | Escitalopram | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 68258-7128-6 | Escitalopram | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
| 68258-7128-9 | Escitalopram | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESCITALOPRAM OXALATE | ACTIVE INGREDIENT | 5U85DBW7LO | ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| ESCITALOPRAM | ACTIVE MOIETY | 4O4S742ANY | ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| HYPROMELLOSE 2208 (100 MPA.S) | INACTIVE INGREDIENT | B1QE5P712K | ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| POLYETHYLENE GLYCOL 300 | INACTIVE INGREDIENT | 5655G9Y8AQ | ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68258-7128 | ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 3 package rows | 20130411_30dc3720-cb57-45dd-bcaa-b92765ceb372.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68258-7128-3 | 68258712803 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 68258-7128-6 | 68258712806 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 68258-7128-9 | 68258712809 | 90 in 1 BOTTLE, PLASTIC | Historical |