Sertraline
- Product NDC
- 64205-965
- 11-digit product format
- 642050965
- Labeler code
- 64205
- Product ID
- 64205-965_52b33a33-da21-4d86-aa55-393db4046b28
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sertraline hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ReadyMeds
- Application
- ANDA077864
- Marketing category
- ANDA
- Marketing start
- 2012-11-06
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 50 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64205-965-30 | Sertraline | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 64205-965-90 | Sertraline | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SERTRALINE HYDROCHLORIDE | ACTIVE INGREDIENT | UTI8907Y6X | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| SERTRALINE | ACTIVE MOIETY | QUC7NX6WMB | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64205-965 | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | Legacy NDC, 2 package rows | 20140515_97f320c5-aa0b-43a8-85e8-c277a5929d97.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 64205-965-30 | 64205096530 | 30 in 1 BOTTLE | Historical |
| 64205-965-90 | 64205096590 | 90 in 1 BOTTLE | Historical |