Sertraline Hydrochloride
- Product NDC
- 68071-1318
- 11-digit product format
- 680711318
- Labeler code
- 68071
- Product ID
- 68071-1318_d6ac4292-0af0-73d1-e053-2a95a90a5176
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare pharmaceuticals,Inc.
- Application
- ANDA077397
- Marketing category
- ANDA
- Marketing start
- 2016-07-21
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-1318-0 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-8c11-f424-e053-dadaa90a57ce | Sertraline Tablets, USP 25mg, 50mg and 100 mg |
| 68071-1318-0 | 2022-01-30 | C162847 | 48780-1 | 9d75b9d0-8c11-f424-e053-dadaa90a57ce | Sertraline Tablets, USP 25mg, 50mg and 100 mg |
| 68071-1318-0 | 2022-01-28 | C162847 | 48780-1 | 9d75b9d0-8c11-f424-e053-dadaa90a57ce | Sertraline Tablets, USP 25mg, 50mg and 100 mg |
| 68071-1318-0 | 2021-01-07 | C162847 | 48780-1 | 9d75b9d0-8c11-f424-e053-dadaa90a57ce | Sertraline Tablets, USP 25mg, 50mg and 100 mg |
| 68071-1318-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8c11-f424-e053-dadaa90a57ce | Sertraline Tablets, USP 25mg, 50mg and 100 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-1318-0 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-1318 | SERTRALINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.] | 3 | Legacy NDC, 1 package rows | 20220129_552cf901-1402-011a-e054-00144ff8d46c.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 |
|---|
| 68071-1318-0 | 68071131800 | 30 TABLET in 1 BOTTLE (68071-1318-0) | 30 tablet | 2017-07-25 | 0000-00-00 | No | No | Current |