Paroxetine
- Product NDC
- 63187-434
- 11-digit product format
- 631870434
- Labeler code
- 63187
- Product ID
- 63187-434_b0100eac-f51f-4aa9-88e1-f628aeea2412
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077584
- Marketing category
- ANDA
- Marketing start
- 2007-04-13
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 40 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
- Paroxetine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 1738483, 1738495, 1738511 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-434-30 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 63187-434-60 | Paroxetine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 63187-434-90 | Paroxetine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | ACTIVE INGREDIENT | X2ELS050D8 | PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| PAROXETINE | ACTIVE MOIETY | 41VRH5220H | PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-434 | PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 3 package rows | 20210115_6318eefa-ee51-4e4e-91a5-8760d48bdc63.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 |
|---|
| 63187-434-30 | 63187043430 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-434-30) | 2015-02-02 | 0000-00-00 | No | No | Current |
| 63187-434-60 | 63187043460 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-434-60) | 2015-02-02 | 0000-00-00 | No | No | Current |
| 63187-434-90 | 63187043490 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-434-90) | 2015-02-02 | 0000-00-00 | No | No | Current |