SERTRALINE HYDROCHLORIDE
- Product NDC
- 71093-143
- 11-digit product format
- 710930143
- Labeler code
- 71093
- Product ID
- 71093-143_ecd3e16c-dc4b-42f1-8213-9ce013299901
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SERTRALINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ACI Healthcare USA, Inc.
- Application
- ANDA076934
- Marketing category
- ANDA
- Marketing start
- 2006-06-30
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 20 mg/mL
- 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 |
|---|
| 71093-143-11 | SERTRALINE HYDROCHLORIDE | 60 mL in 1 BOTTLE, DROPPER | SOLUTION | 60 | | 8 |
| 71093-143-11 | SERTRALINE HYDROCHLORIDE | 1 in 1 CARTON | SOLUTION | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71093-143 | SERTRALINE HYDROCHLORIDE SOLUTION [ACI HEALTHCARE USA, INC.] | 8 | Legacy NDC, 2 package rows | 20231218_f5da1754-2aed-4777-ad2e-593ee43e6e86.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 |
|---|
| 71093-143-11 | 71093014311 | 1 BOTTLE, DROPPER in 1 CARTON (71093-143-11) > 60 mL in 1 BOTTLE, DROPPER | 2018-08-20 | 0000-00-00 | No | No | Current |