Sertraline Hydrochloride
- Product NDC
- 21695-165
- 11-digit product format
- 216950165
- Labeler code
- 21695
- Product ID
- 21695-165_232a00a4-761e-422f-b62a-1a16de631eb6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sertraline hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA077397
- Marketing category
- ANDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 50 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21695-165-30 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 21695-165-60 | Sertraline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 21695-165-90 | Sertraline Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-165 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 3 package rows | 20101210_232a00a4-761e-422f-b62a-1a16de631eb6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-165-30 | 21695016530 | 30 in 1 BOTTLE | Historical |
| 21695-165-60 | 21695016560 | 60 in 1 BOTTLE | Historical |
| 21695-165-90 | 21695016590 | 90 in 1 BOTTLE | Historical |