Sertraline Hydrochloride
- Product NDC
- 63187-795
- 11-digit product format
- 631870795
- Labeler code
- 63187
- Product ID
- 63187-795_46242389-2faa-4900-a43a-643cf388a6d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077397
- Marketing category
- ANDA
- Marketing start
- 2016-07-21
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sertraline Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SERTRALINE HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UTI8907Y6X |
| Rxcui | 312938 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-795-30 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 63187-795-60 | Sertraline Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
| 63187-795-90 | Sertraline Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-795 | SERTRALINE HYDROCHLORIDE TABLET [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 3 package rows | 20200218_787a683a-091c-4908-a643-ecbc8fd467eb.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 |
|---|
| 63187-795-30 | 63187079530 | 30 TABLET in 1 BOTTLE (63187-795-30) | 30 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 63187-795-60 | 63187079560 | 60 TABLET in 1 BOTTLE (63187-795-60) | 60 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 63187-795-90 | 63187079590 | 90 TABLET in 1 BOTTLE (63187-795-90) | 90 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |