SERTRALINE HYDROCHLORIDE
- Product NDC
- 50436-0216
- 11-digit product format
- 504360216
- Labeler code
- 50436
- Product ID
- 50436-0216_e192fce9-3ad7-4952-a7e0-f4b450fd954c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SERTRALINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA202825
- Marketing category
- ANDA
- Marketing start
- 2017-02-09
- 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
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 50436-0216-1 | SERTRALINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 50436-0216-3 | SERTRALINE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50436-0216 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 5 | Legacy NDC, 2 package rows | 20210521_d1324ef1-073f-41bb-a4fd-403f3619958b.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 |
|---|
| 50436-0216-1 | 50436021601 | 30 TABLET, FILM COATED in 1 BOTTLE (50436-0216-1) | 2021-05-20 | 0000-00-00 | No | No | Current |
| 50436-0216-3 | 50436021603 | 90 TABLET, FILM COATED in 1 BOTTLE (50436-0216-3) | 2021-05-20 | 0000-00-00 | No | No | Current |