Paroxetine
- Product NDC
- 43547-350
- 11-digit product format
- 435470350
- Labeler code
- 43547
- Product ID
- 43547-350_48f30016-3f81-4060-887c-6eaf14f17c1c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA203854
- Marketing category
- ANDA
- Marketing start
- 2022-03-29
- 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, 1738503, 1738511 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43547-350-03 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
| 43547-350-09 | Paroxetine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 9 |
| 43547-350-11 | Paroxetine | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 9 |
| 43547-350-50 | Paroxetine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | ACTIVE INGREDIENT | X2ELS050D8 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 1 | |
| PAROXETINE | ACTIVE MOIETY | 41VRH5220H | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 1 | |
| GLYCERYL DIBEHENATE | INACTIVE INGREDIENT | R8WTH25YS2 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-350 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 9 | Current NDC, Legacy NDC, 4 package rows | 20250124_6cfde064-ddcb-49df-a53c-953c40eb1470.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 |
|---|
| 43547-350-03 | 43547035003 | 30 TABLET, FILM COATED in 1 BOTTLE (43547-350-03) | 2022-03-29 | 0000-00-00 | No | No | Current |
| 43547-350-09 | 43547035009 | 90 TABLET, FILM COATED in 1 BOTTLE (43547-350-09) | 2022-03-29 | 0000-00-00 | No | No | Current |
| 43547-350-11 | 43547035011 | 1000 TABLET, FILM COATED in 1 BOTTLE (43547-350-11) | 2022-03-29 | 0000-00-00 | No | No | Current |
| 43547-350-50 | 43547035050 | 500 TABLET, FILM COATED in 1 BOTTLE (43547-350-50) | 2022-03-29 | 0000-00-00 | No | No | Current |