Sertraline Hydrochloride
- Product NDC
- 10135-694
- 11-digit product format
- 101350694
- Labeler code
- 10135
- Product ID
- 10135-694_f568307a-a476-4d9a-9cb4-ca78f9259b21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals Inc
- Application
- ANDA076934
- Marketing category
- ANDA
- Marketing start
- 2020-03-01
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 10135-694-61 | Sertraline Hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 10135-694-61 | Sertraline Hydrochloride | 60 mL in 1 BOTTLE, PLASTIC | SOLUTION | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-694 | SERTRALINE HYDROCHLORIDE SOLUTION [MARLEX PHARMACEUTICALS INC] | 1 | Legacy NDC, 2 package rows | 20200403_c158b751-6957-44fb-bd40-73f25c9f171f.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 |
|---|
| 10135-694-61 | 10135069461 | 1 BOTTLE, PLASTIC in 1 CARTON (10135-694-61) > 60 mL in 1 BOTTLE, PLASTIC | 2020-03-01 | 0000-00-00 | No | No | Current |