Sertraline Hydrochloride
- Product NDC
- 16714-611
- 11-digit product format
- 167140611
- Labeler code
- 16714
- Product ID
- 16714-611_8e670c10-d58c-4b50-96b6-9a67331a29c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA077206
- Marketing category
- ANDA
- Marketing start
- 2007-02-06
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Cytochrome P450 2D6 Inhibitors [MoA], 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UTI8907Y6X |
| Rxcui | 312938, 312940, 312941 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-611-01 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 22 |
| 16714-611-02 | Sertraline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 22 |
| 16714-611-03 | Sertraline Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 22 |
| 16714-611-04 | Sertraline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 22 |
| 16714-611-05 | Sertraline Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 22 |
| 16714-611-06 | Sertraline Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SERTRALINE HYDROCHLORIDE | ACTIVE INGREDIENT | UTI8907Y6X | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | |
| SERTRALINE | ACTIVE MOIETY | QUC7NX6WMB | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-611 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 22 | Current NDC, Legacy NDC, 6 package rows | 20240210_9bc362d4-489c-4e7f-915a-3076ff8d132a.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 |
|---|
| 16714-611-01 | 16714061101 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-611-01) | 2007-02-06 | 0000-00-00 | No | No | Current |
| 16714-611-02 | 16714061102 | 60 TABLET, FILM COATED in 1 BOTTLE (16714-611-02) | 2007-02-06 | 0000-00-00 | No | No | Current |
| 16714-611-03 | 16714061103 | 90 TABLET, FILM COATED in 1 BOTTLE (16714-611-03) | 2007-02-06 | 0000-00-00 | No | No | Current |
| 16714-611-04 | 16714061104 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-611-04) | 2007-02-06 | 0000-00-00 | No | No | Current |
| 16714-611-05 | 16714061105 | 500 TABLET, FILM COATED in 1 BOTTLE (16714-611-05) | 2007-02-06 | 0000-00-00 | No | No | Current |
| 16714-611-06 | 16714061106 | 1000 TABLET, FILM COATED in 1 BOTTLE (16714-611-06) | 2007-02-06 | 0000-00-00 | No | No | Current |