Paroxetine
- Product NDC
- 43353-544
- 11-digit product format
- 433530544
- Labeler code
- 43353
- Product ID
- 43353-544_37d67ac2-1470-43aa-a06d-b24981539fd4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078902
- Marketing category
- ANDA
- Marketing start
- 2008-03-24
- 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 | 1738495, 1738511 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-544-15 | Paroxetine | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | | 3 |
| 43353-544-30 | Paroxetine | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 3 |
| 43353-544-45 | Paroxetine | 45 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 45 | | 3 |
| 43353-544-60 | Paroxetine | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 3 |
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 [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| PAROXETINE | ACTIVE MOIETY | 41VRH5220H | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-544 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20200718_ec9622ca-1f56-4216-9445-485791c4c0ed.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 |
|---|
| 43353-544-15 | 43353054415 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-15) | 2009-09-21 | 0000-00-00 | No | No | Current |
| 43353-544-30 | 43353054430 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-30) | 2019-02-01 | 0000-00-00 | No | No | Current |
| 43353-544-45 | 43353054445 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-45) | 2010-01-12 | 0000-00-00 | No | No | Current |
| 43353-544-60 | 43353054460 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-60) | 2019-03-18 | 0000-00-00 | No | No | Current |