SERTRALINE
- Product NDC
- 61919-416
- 11-digit product format
- 619190416
- Labeler code
- 61919
- Product ID
- 61919-416_3fb439b4-486d-092a-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SERTRALINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA077397
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4ac594ea-ad8b-47fd-9b52-bbd98301675e | Product name | 1 | 20220317 |
| 255fa467-900b-5557-4215-6823352d1150 | Product name | 2 | 20211028 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-416-30 | SERTRALINE | 30 in 1 BOTTLE | TABLET | 30 | 2 | |
| 61919-416-60 | SERTRALINE | 60 in 1 BOTTLE | TABLET | 60 | 2 | |
| 61919-416-90 | SERTRALINE | 90 in 1 BOTTLE | TABLET | 90 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-416-30 | EA - Each | 61919-416 | 20ffb41e-3099-43f5-9824-280fc30dab79 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| SERTRALINE HYDROCHLORIDE | ACTIVE INGREDIENT | UTI8907Y6X | SERTRALINE TABLET [DIRECT RX] | 1 | |
| SERTRALINE | ACTIVE MOIETY | QUC7NX6WMB | SERTRALINE TABLET [DIRECT RX] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SERTRALINE TABLET [DIRECT RX] | 1 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | SERTRALINE TABLET [DIRECT RX] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | SERTRALINE TABLET [DIRECT RX] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | SERTRALINE TABLET [DIRECT RX] | 1 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | SERTRALINE TABLET [DIRECT RX] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | SERTRALINE TABLET [DIRECT RX] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SERTRALINE TABLET [DIRECT RX] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | SERTRALINE TABLET [DIRECT RX] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | SERTRALINE TABLET [DIRECT RX] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SERTRALINE TABLET [DIRECT RX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SERTRALINE TABLET [DIRECT RX] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312938 | sertraline HCl 100 MG Oral Tablet | PSN | 347db8a2-b214-4bb7-953a-2dad1076ab37 | 2 |
| 312941 | sertraline HCl 50 MG Oral Tablet | PSN | 347db8a2-b214-4bb7-953a-2dad1076ab37 | 2 |
| 312938 | sertraline 100 MG Oral Tablet | SCD | 347db8a2-b214-4bb7-953a-2dad1076ab37 | 2 |
| 312941 | sertraline 50 MG Oral Tablet | SCD | 347db8a2-b214-4bb7-953a-2dad1076ab37 | 2 |
| 312938 | sertraline (as sertraline HCl) 100 MG Oral Tablet | SY | 347db8a2-b214-4bb7-953a-2dad1076ab37 | 2 |
| 312941 | sertraline (as sertraline HCl) 50 MG Oral Tablet | SY | 347db8a2-b214-4bb7-953a-2dad1076ab37 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 61919-416-30 | 61919041630 | 30 in 1 BOTTLE | Historical |
| 61919-416-60 | 61919041660 | 60 in 1 BOTTLE | Historical |
| 61919-416-90 | 61919041690 | 90 in 1 BOTTLE | Historical |