Sertraline Hydrochloride
- Product NDC
- 53217-257
- 11-digit product format
- 532170257
- Labeler code
- 53217
- Product ID
- 53217-257_83c89057-ad1c-4039-9122-faec35cb3958
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA077397
- Marketing category
- ANDA
- Marketing start
- 2016-07-21
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 53217-257-15 | Sertraline Hydrochloride | 15 in 1 BOTTLE | TABLET | 15 | | 1 |
| 53217-257-30 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 53217-257-60 | Sertraline Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-257 | SERTRALINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 3 package rows | 20170310_2936b757-b055-492c-ba3e-8bd4249bf9f4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-257-15 | 53217025715 | 15 in 1 BOTTLE | Historical |
| 53217-257-30 | 53217025730 | 30 in 1 BOTTLE | Historical |
| 53217-257-60 | 53217025760 | 60 in 1 BOTTLE | Historical |