Sertraline Hydrochloride
- Product NDC
- 42337-202
- 11-digit product format
- 423370202
- Labeler code
- 42337
- Product ID
- 42337-202_e8c17511-93ca-2cf2-e053-2a95a90a1dde
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sertraline hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Viwit Pharmaceutical Co., Ltd.
- Application
- ANDA076882
- Marketing category
- ANDA
- Marketing start
- 2021-02-28
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 42337-202-01 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 42337-202-02 | Sertraline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 42337-202-03 | Sertraline Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
| 42337-202-04 | Sertraline Hydrochloride | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 1 |
| 42337-202-05 | Sertraline Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42337-202 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [VIWIT PHARMACEUTICAL CO., LTD.] | 1 | Legacy NDC, 5 package rows | 20220922_e8c184d1-d4a0-7777-e053-2995a90a51cc.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 |
|---|
| 42337-202-01 | 42337020201 | 30 TABLET, FILM COATED in 1 BOTTLE (42337-202-01) | 2021-02-28 | 0000-00-00 | No | No | Current |
| 42337-202-02 | 42337020202 | 60 TABLET, FILM COATED in 1 BOTTLE (42337-202-02) | 2021-02-28 | 0000-00-00 | No | No | Current |
| 42337-202-03 | 42337020203 | 90 TABLET, FILM COATED in 1 BOTTLE (42337-202-03) | 2021-02-28 | 0000-00-00 | No | No | Current |
| 42337-202-04 | 42337020204 | 180 TABLET, FILM COATED in 1 BOTTLE (42337-202-04) | 2021-02-28 | 0000-00-00 | No | No | Current |
| 42337-202-05 | 42337020205 | 500 TABLET, FILM COATED in 1 BOTTLE (42337-202-05) | 2021-02-28 | 0000-00-00 | No | No | Current |