SERTRALINE HYDROCHLORIDE
- Product NDC
- 71093-131
- 11-digit product format
- 710930131
- Labeler code
- 71093
- Product ID
- 71093-131_701d9091-1809-4afe-94af-f36fd04c174a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SERTRALINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ACI Healthcare USA, Inc.
- Application
- ANDA076881
- Marketing category
- ANDA
- Marketing start
- 2007-02-06
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 100 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71093-131-01 | SERTRALINE HYDROCHLORIDE | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 6 |
| 71093-131-03 | SERTRALINE HYDROCHLORIDE | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 6 |
| 71093-131-05 | SERTRALINE HYDROCHLORIDE | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71093-131 | SERTRALINE HYDROCHLORIDE TABLET [ACI HEALTHCARE USA, INC.] | 6 | Legacy NDC, 3 package rows | 20230410_1f99e897-1b70-40b0-8c19-71d0bba19422.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71093-131-01 | 71093013101 | 30 TABLET in 1 BOTTLE, PLASTIC (71093-131-01) | 30 tablet | 2018-08-20 | 0000-00-00 | No | No | Current |
| 71093-131-03 | 71093013103 | 90 TABLET in 1 BOTTLE, PLASTIC (71093-131-03) | 90 tablet | 2018-08-20 | 0000-00-00 | No | No | Current |
| 71093-131-05 | 71093013105 | 500 TABLET in 1 BOTTLE, PLASTIC (71093-131-05) | 500 tablet | 2018-08-20 | 0000-00-00 | No | No | Current |