PAROXETINE
- Product NDC
- 61919-658
- 11-digit product format
- 619190658
- Labeler code
- 61919
- Product ID
- 61919-658_f2152dab-c7ce-3e59-e053-2995a90a3120
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PAROXETINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA077584
- Marketing category
- ANDA
- Marketing start
- 2019-04-19
- Marketing end
- 0000-00-00
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2024-12-31
- 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 |
|---|
| 61919-658-30 | PAROXETINE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
| 61919-658-60 | PAROXETINE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 9 |
| 61919-658-90 | PAROXETINE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PAROXETINE HYDROCHLORIDE ANHYDROUS | ACTIVE INGREDIENT | 3I3T11UD2S | PAROXETINE TABLET, FILM COATED [DIRECT RX] | 1 | |
| PAROXETINE | ACTIVE MOIETY | 41VRH5220H | PAROXETINE TABLET, FILM COATED [DIRECT RX] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | PAROXETINE TABLET, FILM COATED [DIRECT RX] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | PAROXETINE TABLET, FILM COATED [DIRECT RX] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PAROXETINE TABLET, FILM COATED [DIRECT RX] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PAROXETINE TABLET, FILM COATED [DIRECT RX] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | PAROXETINE TABLET, FILM COATED [DIRECT RX] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PAROXETINE TABLET, FILM COATED [DIRECT RX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PAROXETINE TABLET, FILM COATED [DIRECT RX] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-658 | PAROXETINE TABLET, FILM COATED [DIRECT RX] | 9 | Legacy NDC, 3 package rows | 20230511_fce8fb27-554b-43e2-8ec9-fc4ca0b0ab8b.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 |
|---|
| 61919-658-30 | 61919065830 | 30 TABLET, FILM COATED in 1 BOTTLE (61919-658-30) | 2019-04-19 | 0000-00-00 | No | No | Current |
| 61919-658-60 | 61919065860 | 60 TABLET, FILM COATED in 1 BOTTLE (61919-658-60) | 2019-04-19 | 0000-00-00 | No | No | Current |
| 61919-658-90 | 61919065890 | 90 TABLET, FILM COATED in 1 BOTTLE (61919-658-90) | 2019-04-19 | 0000-00-00 | No | No | Current |